BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [STERLING/GREY] TESTED FOR USE WITH CHEMOTHERAPHY DRUGS is a disposable device intended for medical purpose worn on the examiners hand or finger to prevent contamination between patient and examiner.

The tested chemotherapy drugs and their breakthrough detection times are as follows:

Test Chemotherapy Drug Name and Concentration

· Carmustine (BCNU) (3.3mg/ml),(3.300 ppm)
· Cisplatin(1.0mg/ml), (1,000 ppm)
· Cyclophosphamide/Cytoxan(20mg/ml), (20,000 ppm)
· Dacarbazine(DTIC) 10mg/ml, (10,000 ppm)
· Doxorubicin HCL(2mg/ml),(2,000 ppm)
· Etoposide /Toposar (20mg/ml), (20,000 ppm)
· Fluorouracil(50mg/ml), (50,000 ppm)
· Ifosfamide (50mg/ml), (50,000 ppm)
· Mitoxantrone(2mg/ml),(2,000 ppm)
· Paclitaxel/Taxol(6.0mg/ml),(6.000 ppm)
· Thiotepa (10mg/ml),(10,000 ppm)
· Vincristine Sulfate(1.0mg/ml),(1,000 ppm)

Please note that the following drugs have extremely low permeation times: Carmustine (BCNU) 5.4 minutes and Thiotepa 40.4 minutes.

Minimum Breakthrough Detection Time
5.4 Minutes

240 Minutes
240 Minutes
240 Minutes
240 Minutes
240 Minutes
240 Minutes
240 Minutes
240 Minutes
240 Minutes
40.4 Minutes
240 Minutes

Device Description

The subject device in this 510(k) Notification is a Sterling/Grey Nitrile Examination gloves, with claims and tested for use with Chemotherapy drugs.

The subject device is a patient examination glove made from nitrile compound, Sterling or Grev in color, powder free and non sterile (as per 21 CFR 880.6250, class I).

The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.

This device is manufactured in facilities compliant to ISO 9001:2008 certified in Manufacture of Non Sterile Natural (Latex) and Synthetic Latex (Nitrile) Examination, Surgical and Industrial Gloves & Nitrile Sheath

The device is manufactured to comply with ISO 13485:2003 / EN ISO 13485:2012 Manufacture of Non Sterile Natural (Latex) and Synthetic Latex (Nitrile) Examination & Sterile Surgical Gloves

AI/ML Overview

This document describes the premarket notification (510(k)) for "BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [STERLING/GREY] TESTED FOR USE WITH CHEMOTHERAPHY DRUGS". The acceptance criteria and the study proving the device meets these criteria are outlined through a comparison with a legally marketed predicate device (K151750).

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic / Test	Acceptance Criteria (Predicate K151750 and general standards)	Reported Device Performance (Subject Device K161215)	Comments / Proof of Meeting Criteria
General
Device Type	Patient Examination Glove (21 CFR 880.6250)	Nitrile Examination Gloves, Powder Free	Same
Intended Use	Prevent contamination between patient and examiner. Tested for use with chemotherapy drugs.	Prevent contamination between patient and examiner. Tested for use with chemotherapy drugs.	Same
Material	Nitrile	Nitrile	Same
Sterility	Non-Sterile	Non-Sterile	Same
Single Use	Yes	Yes	Same
Design	Meet Requirements of ASTM D6319	Meet Requirements of ASTM D6319	Same (Implied by standard compliance)
Physical Properties	Meets Requirements of ASTM D6319	Meets Requirements of ASTM D6319	Same
Dimensions
Length	min 230 mm / ≥ 230mm, Meets Requirements of ASTM D6319	minimum 230 mm, target 242 mm, maximum 258 mm, Meets Requirements of ASTM D6319	Same
Thickness (Cuff)	0.032-0.050 mm	0.05-0.07 mm	Meets requirements of ASTM D6319. (While the ranges differ, both are stated to meet the standard, indicating the subject device's range is within acceptable limits of the standard.)
Thickness (Palm)	0.055-0.085 mm	0.06-0.09 mm	Meets requirements of ASTM D6319.
Thickness (Finger)	0.065-0.095 mm	0.07-0.10 mm	Meets requirements of ASTM D6319.
Performance - Barrier
Powder Free Residue	≤ 2mg/glove	≤ 2mg/glove	Same
Freedom from pinholes testing	Tested in accordance with ASTM D5151 test method. Pass quality level at G1 AQL 1.5	Tested in accordance with ASTM D5151 test method. Pass quality level at G2 AQL 1.0	Subject device tested to a more stringent criteria of G2 AQL 1.0
Performance - Chemotherapy Drug Permeation	(Based on predicate performance and "above 30 minutes permeation time" criteria for some drugs)
Carmustine (BCNU) (3.3mg/ml)	10.1 minutes (Predicate) / "Below 30 minutes permeation time"	5.4 minutes	Below 30 minutes permeation time, same as the predicate device. A warning statement is included.
Cisplatin (1.0mg/ml)	>240 minutes	>240 minutes	Same
Cyclophosphamide/Cytoxan (20mg/ml)	>240 minutes	>240 minutes	Same
Dacarbazine (DTIC) 10mg/ml	>240 minutes	>240 minutes	Same
Doxorubicin HCL (2mg/ml)	>240 minutes	>240 minutes	Same
Etoposide /Toposar (20mg/ml)	Not explicitly listed for predicate, assumed >240 as per other drugs	>240 minutes	Implicitly meets, with similar performance to most other listed drugs.
Fluorouracil (50mg/ml)	>240 minutes	>240 minutes	Same
Ifosfamide (50mg/ml)	>240 minutes	>240 minutes	Same
Mitoxantrone (2mg/ml)	>240 minutes	>240 minutes	Same
Paclitaxel/Taxol (6.0mg/ml)	>240 minutes	>240 minutes	Same
Thiotepa (10mg/ml)	30.2 minutes (Blue Predicate), 10.4 minutes (White Predicate)	40.4 minutes	Subject device had a permeation time of 40.4 mins which exceeded 30 mins, but less than 60 mins. A warning statement is included.
Vincristine Sulfate (1.0mg/ml)	>240 minutes	>240 minutes	Same
Biocompatibility
Dermal Sensitization (ISO 10993-10:2010)	Not a contact sensitizer under the conditions of the study	Not a contact sensitizer under the conditions of the study	Same
Primary Skin Irritation Test (ISO 10993-10:2010)	Not a primary skin irritant under the conditions of the study	Not a primary skin irritant under the conditions of the study	Same
Systemic Toxicity (ISO 10993-11)	(Predicate not tested)	No mortality or no evidence of Systemic Toxicity was observed	Predicate device was not tested for Systemic Toxicity. Subject device was tested for Acute Systemic Toxicity and no mortality or evidence of Systemic Toxicity was observed.

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample sizes for the various tests (e.g., pinhole, chemotherapy permeation, physical properties, biocompatibility). It references standardized test methods (ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, ISO 10993-10:2010, 16 CFR Part 1500.41) which typically define appropriate sample sizes. The data provenance is non-clinical performance data, likely generated prospectively by the manufacturer and/or a testing laboratory contracted by the manufacturer. The country of origin of the data is not specified beyond the manufacturer being based in Malaysia.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable. The device is a patient examination glove, and its performance is evaluated against objective, standardized physical, chemical, and biological tests, not against expert interpretation of medical images or other diagnostic data where ground truth would be established by human experts.

4. Adjudication method for the test set

This section is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or subjective assessments, often in clinical trials or comparative imaging studies. The testing described here is based on objective, standardized laboratory methods.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. MRMC studies and the concept of AI assistance for human readers are relevant for diagnostic devices (e.g., AI for radiology interpretation). The device in question is a medical glove, for which such a study design is not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This section is not applicable. The device is a physical medical glove, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance claims of this device is established through:

Standardized Test Methods and Specifications: Adherence to ASTM D6319-10 (Standard specification for Nitrile Examination Gloves), ASTM D5151-06 (standard for pinholes), ASTM D6124-06 (standard for powder residue), ISO 10993-10:2010 (biocompatibility - irritation and sensitization), ISO 10993-11 (biocompatibility - systemic toxicity), and 16 CFR Part 1500.41 (flammability).
Predicate Device Performance: The performance of the legally marketed predicate device (K151750) serves as a benchmark for substantial equivalence, particularly concerning chemotherapy drug permeation.

8. The sample size for the training set

This section is not applicable. A "training set" refers to data used to train machine learning models. This device is a physical product and does not involve AI or machine learning algorithms.

9. How the ground truth for the training set was established

This section is not applicable for the reasons stated in point 8.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 21, 2016

Brightway Holdings Sdn Bhd G. Baskaran Group Managing Director Lot 1559, Jalan Istimewa, Batu Belah Klang, 42100 MY

Re: K161215

Trade/Device Name: Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: November 16, 2016 Received: November 21, 2016

Dear G. Baskaran:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K161215

Device Name

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [STERLING/GREY] TESTED FOR USE WITH CHEMOTHERAPHY DRUGS

Indications for Use (Describe)

The tested chemotherapy drugs and their breakthrough detection times are as follows:

Test Chemotherapy Drug Name and Concentration

· Carmustine (BCNU) (3.3mg/ml),(3.300 ppm)
· Cisplatin(1.0mg/ml), (1,000 ppm)
· Cyclophosphamide/Cytoxan(20mg/ml), (20,000 ppm)
· Dacarbazine(DTIC) 10mg/ml, (10,000 ppm)
· Doxorubicin HCL(2mg/ml),(2,000 ppm)
· Etoposide /Toposar (20mg/ml), (20,000 ppm)
· Fluorouracil(50mg/ml), (50,000 ppm)
· Ifosfamide (50mg/ml), (50,000 ppm)
· Mitoxantrone(2mg/ml),(2,000 ppm)
· Paclitaxel/Taxol(6.0mg/ml),(6.000 ppm)
· Thiotepa (10mg/ml),(10,000 ppm)
· Vincristine Sulfate(1.0mg/ml),(1,000 ppm)

Please note that the following drugs have extremely low permeation times: Carmustine (BCNU) 5.4 minutes and Thiotepa 40.4 minutes.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

Minimum Breakthrough Detection Time

5.4 Minutes

240 Minutes

40.4 Minutes

240 Minutes

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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FORM FDA 3881 (8/14)

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510(K) SUMMARY

K161215

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [STERLING/GREY] TESTED FOR USE WITH CHEMOTHERAPHY DRUGS

1. Submitter :

Company Name :	BRIGHTWAY HOLDINGS SDN. BHD.
Street Address:	Lot 1559, Jalan Istimewa,
	Batu Belah, 42100 Klang
	Selangor Darul Ehsan.
Country:	Malaysia
Phone No. :	603-3343 1007 & 603-3343 1094.
Fax No. :	603-3341 4800
E-mail Address :	brightway@brightway919.com
Contact Person :	Mr. G. Baskaran (Group Managing Director)
	baskar@brightway919.com
	Mr. Felix Darrel (Group Marketing Manager)
	felix.marketing@brightway919.com

30th November 2016 2. Preparation Date :
1. Name of the Device :

Device trade or proprietary name: BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [STERLING/GREY] TESTED FOR USE WITH CHEMOTHERAPHY DRUGS

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Device Classification Name: Polymer Patient Examination Glove (21 CFR 88.6250)

Device common or usual name: NITRILE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPHY DRUGS

FDA Device Class: Class 1

Product Code: LZA, LZC

4. Identification of the Device :

Class I patient Examination glove and tested for use with Chemotherapy Drugs, Powder Free, LZC, which meets all the requirement of ASTM D 6319-10 and FDA 21 CFR 880.6250.

5. Device Description:

The subject device in this 510(k) Notification is a Sterling/Grey Nitrile Examination gloves, with claims and tested for use with Chemotherapy drugs.

The subject device is a patient examination glove made from nitrile compound, Sterling or Grev in color, powder free and non sterile (as per 21 CFR 880.6250, class I).

The device is manufactured to comply with ISO 13485:2003 / EN ISO 13485:2012 Manufacture of Non Sterile Natural (Latex) and Synthetic Latex (Nitrile) Examination & Sterile Surgical Gloves

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6. Intended use of the Device

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [STERLING/GREY] TESTED FOR USE WITH CHEMOTHERAPHY DRUGS is a disposable device intended for medical purpose worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The tested chemotherapy drugs and their breakthrough detection times are as follows:

Test Chemotherapy Drug Name and Concentration	Minimum Breakthrough Detection Time
• Carmustine (BCNU) (3.3mg/ml),(3,300 ppm)	5.4 Minutes
• Cisplatin(1.0mg/ml), (1,000 ppm)	>240 Minutes
• Cyclophosphamide/Cytoxan(20mg/ml), (20,000 ppm)	>240 Minutes
• Dacarbazine(DTIC) 10mg/ml, (10,000 ppm)	>240 Minutes
• Doxorubicin HCL(2mg/ml),(2,000 ppm)	>240 Minutes
• Etoposide /Toposar (20mg/ml), (20,000 ppm)	>240 Minutes
• Fluorouracil (50mg/ml), (50,000 ppm)	>240 Minutes
• Ifosfamide (50mg/ml), (50,000 ppm)	>240 Minutes
• Mitoxantrone(2mg/ml),(2,000 ppm)	>240 Minutes
• Paclitaxel/Taxol(6.0mg/ml),(6,000 ppm)	>240 Minutes
• Thiotepa (10mg/ml),(10,000 ppm)	40.4 Minutes
• Vincristine Sulfate(1.0mg/ml),(1,000 ppm)	>240 Minutes

Please note that the following drugs have extremely low permeation times: Carmustine (BCNU) 5.4 minutes and Thiotepa 40.4 minutes.

7. Substantial Equivalence Based on Assessment of Non-Clinical Performance Data

Testing was performed per ASTM D6319-10 , ASTM D5151-06, ASTM D6124- 06,ISO 10993-10:2010 and 16 CFR Part 1500.41.

Biocompatibility tests indicated that under the conditions of the studies, the gloves were nonsensitizing, non-irritating, and non-systemically toxic

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8. Legally Marketed Device to which Substantial Equivalence is Claimed

The legally marketed predicate device in scope is as follows:

1. K151750 Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile

Substantial Equivalence Comparison Table:

The subject Device, K161215 - BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPHY CLAIM is substantially equivalent in safety and effectiveness to K151750 - Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile

The subject device and predicate device use a similar Nitrile barrier film to achieve a device for the intended use. The properties between the subject device and the predicate device are compared in the following table:

Characteristics	Subject DeviceK161215	Predicate DeviceK151750	Comments
	Sterling/Grey	Blue, White
Manufacturer	Brightway Holdings Sdn Bhd	Kossan International Sdn Bhd	N/A
510(K) Number	K161215	K151750	N/A
Identification	Nitrile Examination Gloves, Powder Free,Sterling/Grey Coloured, Tested For Use with Chemotherapy Drugs	1. Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs2. Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs	N/A
Device Classification Name/Regulation Number	Patient Examination Glove/21 CFR Part 880.6250	Patient Examination Glove/21 CFR Part 880.6250	Same
Product Code	LZA, LZC	LZA, LZC	Same
	BRIGHTWAY BRANDNITRILE EXAMINATIONGLOVES, POWDER FREE,[STERLING/GREY] TESTEDFOR USE WITHCHEMOTHERAPHYDRUGS is a disposabledevice intended formedical purpose worn onthe examiner's hand orfinger to preventcontamination betweenpatient and examiner.	A patient examinationglove is a disposabledevice intended formedical purposes that isworn on the examiner'shand to preventcontamination betweenpatient and examiner.These gloves weretested for use withchemotherapy drugsper ASTM D6978-05(Reapproved 2013)Standard Practice forAssessment of MedicalGloves to Permeationby Chemotherapy Drugs
Intended Use		Same	Same
Materials	Nitrile	Nitrile	Same
Color	Grey / Sterling	Blue, and White	The difference incolor doesnot raise anysafety issues
Design	Meet Requirements ofASTM D6319	Extra SmallSmallMediumLargeExtra LargeDouble Extra Large	Same
Single Use	Yes	Yes	Same
Sterility	Non-Sterile	Non-Sterile	Same
Length	minimum 230 mm,target 242 mm,maximum 258 mm,Meets Requirements ofASTM D6319	min 230 mm / ≥230mm, MeetsRequirements of ASTMD6319	Same
Thickness(mm)			Meetsrequirements ofASTM D6319Subject Device
Cuff	0.05-0.07	0.032-0.050
Palm	0.06-0.09	0.055-0.085	Meetsrequirements ofASTM D6319
Finger	0.07-0.10	0.065-0.095	Meetsrequirements ofASTM D6319
Powder Free Residue	≤ 2mg/glove	≤ 2mg/glove	Same
Physical Properties	Meets Requirements ofASTM D6319	Meets Requirements ofASTM D6319	Same
Freedom from pinholestesting	Tested in accordancewith ASTM D5151 testmethod. Pass quality levelat G2 AQL 1.0	Tested in accordancewith ASTM D5151 testmethod. Pass qualitylevel at G1 AQL 1.5	Tested to Samestandard. Subjectdevice tested to amore stringentcriteria of G2 AQL1.0
Biocompatibility Test
Dermal Sensitization (asISO 10993- 10:2010)	Not a contact sensitizerunder theconditions of the study	Not a contact sensitizerunder theconditions of the study	Same
Primary Skin IrritationTest (as ISO 10993-10:2010)	Not a primary skin irritantunder theconditions of the study	Not a primary skinirritant underthe conditions of thestudy	Same

Systemic Toxicity (ISO10993-11)	Under the conditions ofthe study, no mortality orno evidence of SystemicToxicity was observed	N/A	Predicate devicewas not testedfor SystemicToxicity, Subjectdevice was testedfor AcuteSystemic Toxicityand no mortalityor evidence ofSystemic Toxicitywas observed
Labelling Features	- Non-sterile- Powder Free- Examination Gloves- Ambidextrous, by Size- Single Use Only- Device Color- Manufactured Date :- Lot Number:- Quantity by Weight- Made in Malaysia	- Non-sterile- Powder Free- Examination Gloves- Ambidextrous, by Size- Single Use Only- Device Color- Manufactured for:- Lot Number:- Quantity by Weight- Made in Malaysia	Same
Chemotherapy DrugsPermeation Test
Chemotherapy Drugs(Concentrations)	Minimum BreakthroughDetection Time inMinutes	Minimum BreakthroughDetection Time inMinutes
• Carmustine (BCNU)(3.3mg/ml),(3,300 ppm)	5.4	10.1	Below 30 minutespermeation time,same as thepredicate device
• Cisplatin (1.0mg/ml),(1,000 ppm)	>240	>240	Same
•Cyclophosphamide/Cytoxan(20mg/ml), (20,000ppm)	>240	>240	Same
• Dacarbazine(DTIC)10mg/ml, (10,000 ppm)	>240	>240	Same
• DoxorubicinHCL(2mg/ml),(2,000 ppm)	>240	>240	Same
• Fluorouracil(50mg/ml),(50,000 ppm)	>240	>240	Same
• Ifosfamide (50mg/ml),(50,000 ppm)	>240	>240	Same
• Mitoxantrone(2mg/ml),(2,000 ppm	>240	>240	Same
• Paclitaxel/Taxol(6.0mg/mI),(6,000 ppm)	>240	>240	Same
• Thiotepa(10mg/ml),(10,000 ppm)	40.4	30.2(Blue) and10.4(White)	Predicate device(Blue) at 30.2minutes;and (White)below 30 minutesSubject Devicehad a permeationtime of 40.4 minswhich exceeded30 mins. less than60 mins.
• VincristineSulfate(1.0mg/ml),(1,000ppm)	>240	>240	Same
Warning Statement	WARNING: Not for usewith Carmustine,ThioTEPA	WARNING:Do Not Use withCarmustine andThiotepa	Same
Labelling Claim	Tested for Use withChemotherapy Drugs	Tested for Use withChemotherapy Drugs	Same

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30th November 2016

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11.0 Conclusion

Based on intended uses, technological characteristics and non-clinical performance data, the subject device is substantially equivalent to the predicate device K151750 - Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile

The subject device meets the requirements of ASTM D 6319- 10 standards as well as applicable 21 CFR references, and meets FDA recognized standards, physical properties requirements, pinhole requirements, biocompatibility requirements and labeling claims as shown and discussed above.

Based on the complete list of non-clinical tests, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.