17
劥Ⱇ➿椚㢵倰欰欴⛓ꄴ欽㢫猰〡縟⺫䭍 껻度⚥㕜〵抓瘞㖒럊 罜欴ㅷ㖳竤歋㢵栬用痧♲倰⻋뀿䨾鹎遤增庠㸞䗱〳ꬒ RoomA,6/F Universal lnd.Bldg.60-62 Sha Tsui Road,Tsuen Wan.N.T 荃灣沙咀道60-62號環球實業大廈6樓A室 Tel. : 2402 3902 Fax. : 2402 9963 潘氏(美國)藥業有限公司 POON’ SPHARM (U.S.A.) MEDICINE LIMITED 倞䧭㆞ 倞䧭㆞ 倞䧭㆞ 倞䧭㆞ 倞䧭㆞

DSS OTS PRO HKHC2004002523HC - Poon's PharmThe Company’s sole responsibility is to its Client and this document does not e xonerate parties to a transaction from exercising all their

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Page 1: DSS OTS PRO HKHC2004002523HC - Poon's PharmThe Company’s sole responsibility is to its Client and this document does not e xonerate parties to a transaction from exercising all their

劥Ⱇ➿椚㢵倰欰欴⛓ꄴ欽㢫猰〡縟⺫䭍껻度⚥㕜〵 抓瘞㖒럊罜欴ㅷ㖳竤歋㢵栬用痧♲倰⻋뀿䨾鹎遤增庠㸞䗱〳ꬒ

RoomA,6/F Universal lnd.Bldg.60-62 Sha Tsui Road,Tsuen Wan.N.T荃灣沙咀道60-62號環球實業大廈6樓A室Tel. : 2402 3902 Fax. : 2402 9963

潘氏(美國)藥業有限公司POON’SPHARM (U.S.A.) MEDICINE LIMITED

倞䧭㆞

倞䧭㆞ 倞䧭㆞ 倞䧭㆞

倞䧭㆞

Page 2: DSS OTS PRO HKHC2004002523HC - Poon's PharmThe Company’s sole responsibility is to its Client and this document does not e xonerate parties to a transaction from exercising all their

话蒀 涯蒀

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RoomA,6/F Universal lnd.Bldg.60-62 Sha Tsui Road,Tsuen Wan.N.T荃灣沙咀道60-62號環球實業大廈6樓A室Tel. : 2402 3902 Fax. : 2402 9963

潘氏(美國)藥業有限公司POON’SPHARM (U.S.A.) MEDICINE LIMITED

䧭➃ ⚥留⿻洅➃㡦

Page 3: DSS OTS PRO HKHC2004002523HC - Poon's PharmThe Company’s sole responsibility is to its Client and this document does not e xonerate parties to a transaction from exercising all their

劥Ⱇ➿椚⛓〡縟䲿⣘欰欴鋊眕ㄤ增庠㜡デ㥶♴ㅷ晦そ珖�.&%�0/ꌼ㈒㖒� ⫦⣘껻度姘崎繡㕜ꌼ㈒⚥俒そ珖�ꄴ欽㢫猰〡縟话蒀栬用⺫酤薊俒そ珖�463(*$"-�'"$&�."4,�����1-:�463(*$"-�'*-5&3�."4,��㘗贫����������������������������������������������������������������������������������������������������������������������� "�TJ[F������Y����DN� #�TJ[F������Y����DN��妵䒭����������������������������������������������������������������������������������������������������������������������

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RoomA,6/F Universal lnd.Bldg.60-62 Sha Tsui Road,Tsuen Wan.N.T荃灣沙咀道60-62號環球實業大廈6樓A室Tel. : 2402 3902 Fax. : 2402 9963

潘氏(美國)藥業有限公司POON’SPHARM (U.S.A.) MEDICINE LIMITED

䧭➃ ⚥留⿻洅➃㡦

Page 4: DSS OTS PRO HKHC2004002523HC - Poon's PharmThe Company’s sole responsibility is to its Client and this document does not e xonerate parties to a transaction from exercising all their

劥Ⱇ➿椚⛓〡縟䲿⣘欰欴鋊眕ㄤ增庠㜡デ㥶♴ㅷ晦そ珖�.&%�0/ꌼ㈒㖒� ⫦⣘껻度ꌼ㈒⚥俒そ珖�ꄴ欽㢫猰〡縟랱蒀禺薊俒そ珖�463(*$"-�'"$&�."4,�����1-:�463(*$"-�'*-5&3�."4,��㘗贫����������������������������������������������������������������������������������������������������������������������� "�TJ[F������Y����DN��妵䒭����������������������������������������������������������������������������������������������������������������������

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RoomA,6/F Universal lnd.Bldg.60-62 Sha Tsui Road,Tsuen Wan.N.T荃灣沙咀道60-62號環球實業大廈6樓A室Tel. : 2402 3902 Fax. : 2402 9963

潘氏(美國)藥業有限公司POON’SPHARM (U.S.A.) MEDICINE LIMITED

랱蒀

Page 5: DSS OTS PRO HKHC2004002523HC - Poon's PharmThe Company’s sole responsibility is to its Client and this document does not e xonerate parties to a transaction from exercising all their

劥Ⱇ➿椚⛓〡縟䲿⣘欰欴鋊眕ㄤ增庠㜡デ㥶♴ㅷ晦そ珖�.&%�0/ꌼ㈒㖒� ⫦⣘껻度姘崎繡㕜ꌼ㈒⚥俒そ珖�ꄴ欽㢫猰〡縟䕙赙禺薊俒そ珖�463(*$"-�'"$&�."4,�����1-:�463(*$"-�'*-5&3�."4,��㘗贫����������������������������������������������������������������������������������������������������������������������� "�TJ[F������Y����DN� #�TJ[F������Y����DN��妵䒭����������������������������������������������������������������������������������������������������������������������

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RoomA,6/F Universal lnd.Bldg.60-62 Sha Tsui Road,Tsuen Wan.N.T荃灣沙咀道60-62號環球實業大廈6樓A室Tel. : 2402 3902 Fax. : 2402 9963

潘氏(美國)藥業有限公司POON’SPHARM (U.S.A.) MEDICINE LIMITED

䧭➃ ⚥留⿻洅➃㡦

Page 6: DSS OTS PRO HKHC2004002523HC - Poon's PharmThe Company’s sole responsibility is to its Client and this document does not e xonerate parties to a transaction from exercising all their
Page 7: DSS OTS PRO HKHC2004002523HC - Poon's PharmThe Company’s sole responsibility is to its Client and this document does not e xonerate parties to a transaction from exercising all their
Page 8: DSS OTS PRO HKHC2004002523HC - Poon's PharmThe Company’s sole responsibility is to its Client and this document does not e xonerate parties to a transaction from exercising all their
Page 9: DSS OTS PRO HKHC2004002523HC - Poon's PharmThe Company’s sole responsibility is to its Client and this document does not e xonerate parties to a transaction from exercising all their
Page 10: DSS OTS PRO HKHC2004002523HC - Poon's PharmThe Company’s sole responsibility is to its Client and this document does not e xonerate parties to a transaction from exercising all their

Test Report No. HKHC2004002523HC Date : May 05, 2020 Page 1 of 4

This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at http://www.sgs.com/en/Terms-and-Conditions.aspx and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at http://www.sgs.com/en/Terms-and-Conditions/Terms-e-Document.aspx. Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. This document cannot be reproduced except in full, without prior written approval of the Company. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law. Unless otherwise stated the results shown in this test report refer only to the sample(s) tested and such sample(s) are retained for 30 days only.

POONSPHARM (USA) MEDICINE LTD FLAT A, 6/F, UNIVERSAL INDUSTRIAL BUILDING, 60-62 SHA TSUI ROAD, TSUEN WAN, HONG KONG Job No. : HKHC200400001275 The following sample was submitted and identified by the client as 3 ply Surgical Filter Mask, 3-Ply Comfort Surgical Face Mask, Disposable Medicine Face Mask, Surgical Face Mask, Disposable Medical Face Mask Product Description : 3 ply Surgical Filter Mask, 3-Ply Comfort Surgical Face Mask,

Disposable Medicine Face Mask, Surgical Face Mask, Disposable Medical Face Mask

Quantity Received : 2 bags x 10 pcs/bag Sample Appearance : Blue mask SGS Sample No. : HKHC200400001275-101 Sample Receiving Condition : In unopened plastic pack under ambient condition Manufacturer / Supplier : Poonspharm (USA) Medicine Ltd Sample Receiving Date : Apr 09, 2020 Testing Period : Apr 09, 2020 – May 05, 2020

Test Requested 1. To perform Particle Filtration Efficiency Test on the submitted sample. 2. To perform Viral Filtration Efficiency test on the submitted sample. Test Methods and Test Results Please refer to the following page(s).

********** Signed for and on behalf of SGS Hong Kong Ltd.

_________________________________________ WONG KIN MAN, GILMAN TECHNICAL DEVELOPMENT MANAGER - COSMETICS, PERSONAL CARE & HOUSEHOLD SERVICES

Apple
Apple
Apple
Apple
Apple
Apple
Page 11: DSS OTS PRO HKHC2004002523HC - Poon's PharmThe Company’s sole responsibility is to its Client and this document does not e xonerate parties to a transaction from exercising all their

Test Report No. HKHC2004002523HC Date : May 05, 2020 Page 2 of 4

This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at http://www.sgs.com/en/Terms-and-Conditions.aspx and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at http://www.sgs.com/en/Terms-and-Conditions/Terms-e-Document.aspx. Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. This document cannot be reproduced except in full, without prior written approval of the Company. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law. Unless otherwise stated the results shown in this test report refer only to the sample(s) tested and such sample(s) are retained for 30 days only.

Test Methods and Test Results 1. Particle Filtration Efficiency Test Summary This procedure was performed to evaluate the non-viable particle filtration efficiency (PFE) of the test article. Monodispersed polystyrene latex spheres (PSL) were nebulized (atomized), dried, and passed through the test article. The particles that passed through the test article were enumerated using a laser particle counter. Three one-minute counts were performed, with the test article in the system, and the results averaged. Three one-minute control counts were performed, without a test article in the system, before and after each test article and the counts were averaged. Control counts were performed to determine the average number of particles delivered to the test article. The filtration efficiency was calculated using the average number of particles penetrating the test article compared to the average of the control values. The procedure employed the basic particle filtration method described in ASTM F2299, with some exceptions; notably the procedure incorporated a non-neutralized challenge. In real use, particles carry a charge, thus this challenge represents a more natural state. The non-neutralized aerosol is also specified in the FDA guidance document on surgical face masks. All test method acceptance criteria were met. Test Side : Blue Side Area Tested : 91.5 cm2 Particle Size : 0.1 µm Laboratory Conditions : 20oC, 24% relative humidity (RH) at 9:14 pm; 21oC, 24%

RH at 10:02 pm Average Filtration Efficiency : 99.84 % Standard Deviation : 0.057 Results:

Test Article Number Average Test Article Counts

Average Control Counts

Filtration Efficiency (%)

1 22 12,503 99.82 2 29 12,798 99.77 3 9 12,706 99.929 4 18 12,578 99.86 5 21 12,576 99.83

Note: 1. Results reported on the submitted sample on an as received basis. 2. The analysis was performed by a SGS assessed competent subcontractor laboratory.

**********

Apple
Apple
Apple
Apple
Page 12: DSS OTS PRO HKHC2004002523HC - Poon's PharmThe Company’s sole responsibility is to its Client and this document does not e xonerate parties to a transaction from exercising all their

Test Report No. HKHC2004002523HC Date : May 05, 2020 Page 3 of 4

This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at http://www.sgs.com/en/Terms-and-Conditions.aspx and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at http://www.sgs.com/en/Terms-and-Conditions/Terms-e-Document.aspx. Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. This document cannot be reproduced except in full, without prior written approval of the Company. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law. Unless otherwise stated the results shown in this test report refer only to the sample(s) tested and such sample(s) are retained for 30 days only.

2. Viral Filtration Efficiency (VFE) Summary: The VFE test is performed to determine the filtration efficiency of test articles by comparing the viral control counts upstream of the test article to the counts downstream. A suspension of bacteriophage ФX174 was aerosolized using a nebulizer and delivered to the test article at a constant flow rate and fixed air pressure. The challenge delivery was maintained at 1.1 – 3.3 x 103 plaque forming units (PFU) with a mean particle size (MPS) of 3.0 µm ± 0.3 µm. The aerosol droplets were drawn through a six-stage, viable particle, Andersen sampler for collection. The VFE test procedure was adapted from ASTM F2101. Test Side: White Side Test Area : ~40 cm2 VFE Flow Rate : 28.3 Liters per minutes (L/min) Conditioning Parameters : 85 ± 5% relative humidity (RH) and 21 ± 5% for a minimum of 4 hours Positive Control Average : 3.3 x 103 PFU Negative Monitor Count : <1 PFU MPS : 2.9 µm

Test Results

Parameter Viral Filtration Efficiency (VFE)

Test Article Number

3 ply Surgical Filter Mask, 3-Ply Comfort Surgical Face Mask, Disposable Medicine Face Mask, Surgical Face Mask, Disposable

Medical Face Mask SGS Sample No.:

HKHC200400001275-101 1 99.8 % 2 99.8 % 3 99.7 % 4 99.8 % 5 99.7 %

The filtration efficiency percentages were calculated using the following equation:

C = Positive control average T = Plate count total recovered downstream of the test article Note: 1. Results reported on the submitted sample on an as received basis. 2. The analysis was performed by a SGS assessed competent subcontractor laboratory.

**********

% VFE = C – T x 100 C

Apple
Apple
Apple
Apple
Apple
Apple
Apple
Page 13: DSS OTS PRO HKHC2004002523HC - Poon's PharmThe Company’s sole responsibility is to its Client and this document does not e xonerate parties to a transaction from exercising all their

Test Report No.: 721654071-10

Report Date: 30 April 2020

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TEST REPORT

Sample Description : Surgical Face Mask

Sample Quantity : 70 pieces Lot Number/Batch Code : / Specification : YY-A1 Size : / Type of Mask : Type IIR Brand Name : / Remark: The above information was provided by applicant.

Summary of Test Results

No. Test Item Test Standard Judgement

1 Bacterial Filtration Efficiency (BFE) Test EN 14683:2019+AC:2019(E) Annex B Pass

2 Differential Pressure Test EN 14683:2019+AC:2019(E) Annex C Pass

3 Synthetic Blood Penetration Test ISO 22609:2004 Pass

4 Microbial Cleanliness Test EN 14683:2019+AC:2019(E) Annex D Pass

Note: Pass = Meet customer requirements; Fail = Fail customer requirements; # = No comment; N.D. = Not detected.

Photo of Samples

Page 14: DSS OTS PRO HKHC2004002523HC - Poon's PharmThe Company’s sole responsibility is to its Client and this document does not e xonerate parties to a transaction from exercising all their
Page 15: DSS OTS PRO HKHC2004002523HC - Poon's PharmThe Company’s sole responsibility is to its Client and this document does not e xonerate parties to a transaction from exercising all their
Apple
Page 16: DSS OTS PRO HKHC2004002523HC - Poon's PharmThe Company’s sole responsibility is to its Client and this document does not e xonerate parties to a transaction from exercising all their
Page 17: DSS OTS PRO HKHC2004002523HC - Poon's PharmThe Company’s sole responsibility is to its Client and this document does not e xonerate parties to a transaction from exercising all their