BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12", POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM is a disposable device intended for medical purpose, to be worn on the examiners hand or finger to prevent contamination between patient and examiner.

The product has been tested with chemotherapy drugs in accordance with ASTM D6978. The breakthrough detection times are as follows:

Test Chemotherapy Drug Name and Concentration Minimum Breakthrough Detection Time Carmustine (BCNU) (3.3mg/ml),(3,300 ppm) ● 4.3 Minutes >240 Minutes

240 Minutes

10.9 Minutes

240 Minutes

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(6.0mg/ml),(6,000 ppm)
Thiotepa (10mg/ml),(10,000 ppm)
. Vincristine Sulfate(1.0mg/ml),(1,000 ppm)

Please note that Carmustine and Thiotepa have extremely low permeation times of 4.3 minutes and 10.9 minutes, respectively.

Warning: Do not use with Carmustine and Thiotepa.

Device Description

The subject device in this 510(k) Notification is Sterling/Grey coloured 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 Grey in colour, 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 also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy drugs as per ASTM D6978-05

AI/ML Overview

The provided text describes the acceptance criteria and the study that proves the BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12", POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM meets these criteria.

Here's the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristics	Standard	Acceptance Criteria (Predicate Device K081089)	Reported Device Performance (Subject Device)	Result of Comparison
Labeling	N/A	No special labeling claims, no claim of hypoallergenic.	No special labeling claims, no claim of hypoallergenic.	Same
Device Materials	N/A	Nitrile Compound	Nitrile Compound	Same
Colour	N/A	Sterling	Sterling / Grey	Same
Tensile strength (Before and after ageing)	ASTM 6319-10	> 14 MPa	> 14 MPa	Same
Ultimate Elongation (Before and after ageing)	ASTM 6319-10	> 500 %	> 500 %	Same
Freedom from Pinholes	ASTM 6319-10 (FDA 1000 ml water leak test)	Pass	Pass	Same
Dimensions: Length	ASTM 6319-10	> 295 mm	> 295 mm (295 mm minimum - 325 mm)	Same
Dimensions: Width	ASTM 6319-10	70±10 mm to 120±10 mm (sizes XS to XL)	70±10 mm to 120±10 mm (sizes XS to XL)	Same
Dimensions: Thickness	ASTM 6319-10	> 0.05 mm (palm & finger)	> 0.05 mm (Palm: 0.075mm-0.08mm; Finger: 0.085mm-0.10mm)	Same
Residual Powder	ASTM 6319-10	Less than 2 mg per glove; PASS	Less than 2 mg per glove; PASS	Same
Primary Skin Irritation test	ISO 10993-10	Under conditions of the study, not an irritant	Under conditions of the study, not an irritant	Same
Dermal sensitization assay	ISO 10993-10	Under conditions of the study, not a sensitizer	Under conditions of the study, not a sensitizer	Same
Systemic Toxicity	ISO 10993-11	Pass	Pass	Same
Chemical Permeation / Chemotherapy Testing (Breakthrough Detection Time)	ASTM D6978-05	Carmustine and Thiotepa have extremely low permeation times of less than 30 minutes	Carmustine: 4.3 Minutes; Cisplatin: >240 Minutes; Cyclophosphamide/Cytoxan: >240 Minutes; Dacarbazine: >240 Minutes; Doxorubicin HCL: >240 Minutes; Etoposide /Toposar: >240 Minutes; Fluorouracil: >240 Minutes; Ifosfamide: >240 Minutes; Mitoxantrone: >240 Minutes; Paclitaxel: >240 Minutes; Thiotepa: 10.9 Minutes; Vincristine Sulfate: >240 Minutes	Same (for Carmustine and Thiotepa, other drugs exceed the predicate's general criteria)

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

The document does not specify the exact sample sizes for each test mentioned (e.g., how many gloves were tested for pinholes, tensile strength, or chemotherapy permeation). It references standards like ASTM D6319-10 and ASTM D6978-05, which would have their own defined sample size requirements.

The data provenance is from Malaysia, as the submitter, BRIGHTWAY HOLDINGS SDN. BHD., is located in Klang, Selangor Darul Ehsan, Malaysia. The data appears to be prospective as it involves direct testing of the device against established standards.

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

This information is not provided in the document. The acceptance criteria and performance are based on recognized industry standards (ASTM, ISO), meaning the "ground truth" is defined by these standards rather than expert consensus on specific cases. The testing was performed according to these established protocols.

4. Adjudication method for the test set

This information is not applicable/not provided as the evaluation is based on objective measurements against predefined standards (ASTM, ISO) rather than subjective assessment requiring adjudication.

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 is not applicable. The device is an examination glove, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant.

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

This is not applicable. The device is an examination glove, not an algorithm.

7. The type of ground truth used

The ground truth used is based on established industry standards and regulatory requirements. Specifically:

Physical properties (tensile strength, elongation, dimensions, freedom from pinholes, residual powder) are compared against specifications in ASTM D6319-10.
Biocompatibility (primary skin irritation, dermal sensitization, systemic toxicity) is evaluated against ISO 10993-10 and ISO 10993-11 requirements.
Resistance to chemotherapy drug permeation is tested according to ASTM D6978-05.
The overall criteria for patient examination gloves are also linked to FDA 21 CFR 880.6250.

8. The sample size for the training set

This is not applicable. The device is a physical product (gloves), not a machine learning model that requires a training set. The "training" in this context refers to the manufacturing process and quality control, not data training for an algorithm.

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

This is not applicable for the same reason as 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

March 31, 2017

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

Re: K162186

Trade/Device Name: BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12" POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: February 8, 2017 Received: February 23, 2017

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,

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

510(k) Number (if known) K162186

Device Name

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12", POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM

Indications for Use (Describe)

The product has been tested with chemotherapy drugs in accordance with ASTM D6978. The breakthrough detection times are as follows:

Test Chemotherapy Drug Name and Concentration	Minimum Breakthrough Detection Time
• Carmustine (BCNU) (3.3mg/ml),(3,300 ppm)	4.3 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(6.0mg/ml),(6,000 ppm)	>240 Minutes
• Thiotepa (10mg/ml),(10,000 ppm)	10.9 Minutes
• Vincristine Sulfate (1.0mg/ml),(1,000 ppm)	>240 Minutes

Please note that Carmustine and Thiotepa have extremely low permeation times of 4.3 minutes, respectively.

Warning: Do not use with Carmustine and Thiotepa.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(K) SUMMARY

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12", POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM

1. Submitter :

Company Name :	BRIGHTWAY HOLDINGS SDN. BHD.
Street Address :	Lot 1559, Jalan Istimewa,Batu Belah, 42100 KlangSelangor 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.comMr. Felix Darrel (Group Marketing Manager)felix.marketing@brightway919.com

1. Preparation Date : 13th March 2017
1. Name of the Device :

Device trade or proprietary name: BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12″, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM

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Device Classification Name: Polymer Patient Examination Glove

(21 CFR 880.6250)

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

FDA Device Class : Class 1

Product Code : LZC , LZA

4. Identification of the Device :

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

Predicate Device:

Legally Marketed Devices to which Substantial Equivalence is claimed:

K081089 - Kimberly-Clark STERLING* Nitrile & STERLING* NITRILE-EXTRA Powder-Free Exam Gloves with Chemotherapy Drug Use Claim

1. Device Description :
  The subject device in this 510(k) Notification is Sterling/Grey coloured 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 Grey in colour, powder free and non sterile (as per 21 CFR 880.6250, class I).

This device also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy drugs as per ASTM D6978-05

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6. Intended use of the Device

BRIGHTWAY BRAND NITRILE EXAMINATION -GLOVES 12", POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM is a disposable device intended for medical purpose, to be worn on the examiners hand or finger to prevent contamination between patient and examiner.

The product has been tested with chemotherapy drugs in accordance with ASTM D6978. The breakthrough detection times are as follows:

Test Chemotherapy Drug Name and Concentration Minimum Breakthrough Detection Time Carmustine (BCNU) (3.3mg/ml),(3,300 ppm) ● 4.3 Minutes >240 Minutes

240 Minutes

10.9 Minutes

240 Minutes

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(6.0mg/ml),(6,000 ppm)
Thiotepa (10mg/ml),(10,000 ppm)
. Vincristine Sulfate(1.0mg/ml),(1,000 ppm)

Please note that Carmustine and Thiotepa have extremely low permeation times of 4.3 minutes and 10.9 minutes, respectively.

Warning: Do not use with Carmustine and Thiotepa.

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. The glove meet standards requirement referenced in section 6.0 above.

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

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1. Summary of Technical Characteristics and Substantial Equivalence Compared to Predicate Device
  The predicate device in scope is as follows

K081089 - Kimberly-Clark STERLING* Nitrile & STERLING* NITRILE-EXTRA Powder-Free Exam Gloves with Chemotherapy Drug Use Claim

The subject device; BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12", POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM is substantially equivalent in safety and effectiveness to K081089 - Kimberly-Clark STERLING* Nitrile & STERLING* NITRILE-EXTRA Powder-Free Exam Gloves with Chemotherapy Drug Use Claim

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:

		Device Performance
Characteristics	Standard	Predicate Device :K 081089 - Kimberly-Clark STERLINGNitrile & STERLINGNITRILE-EXTRAPowder-Free ExamGloves withChemotherapy DrugUse Claim	Subject Device :BRIGHTWAYBRAND NITRILEEXAMINATIONGLOVES 12",POWDER FREE,[STERLING/GREY]WITHCHEMOTHERAPYCLAIM	Result ofComparison
Labeling	N/A	There are no speciallabeling claims anddo not claim glovesas hypoallergenic onlabels.	There are nospecial labelingclaims and do notclaim gloves ashypoallergenic onlabels.	Same
Device Materials	N/A	Nitrile Compound	Nitrile Compound	Same
Colour	N/A	Sterling	Sterling / Grey	Same

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Device Tolerances and Specifications & Performance Data

Tensile strength :Before and afterageing	ASTM6319-10	> 14 Mpa	> 14 Mpa	Same
Ultimate Elongation :Before and afterageing	ASTM6319-10	> 500 %	> 500 %	Same
Freedom fromPinholes :	ASTM 6319-10(FDA 1000 ml waterleak test)	Pass	Pass	Same
Dimensions:Length	ASTM6319-10	> 295 mm	> 295 mm(295 mm minimum-325 mm)	Same
Width	ASTM6319-10	70±10 mm to120±10 mm (sizes XSto XL)	70±10 mm to120±10 mm (sizes XSto XL)	Same
Thickness	ASTM6319-10	> 0.05 mm (palm &finger)	> 0.05 mm(Palm :0.075mm-0.08mmFinger : 0.085mm-0.10mm)	Same
Residual Powder :	ASTM6319-10,	Less than 2 mg perglove ; PASS	Less than 2 mg perglove ; PASS	Same
Biocompatibility
Primary SkinIrritation test	ISO 10993-10	Under conditions ofthe study, not anirritant	Under conditions ofthe study, not anirritant	Same
Dermal sensitizationassay	ISO 10993-10	Under conditions ofthe study, not asensitizer	Under conditions ofthe study, not asensitizer	Same
Systemic Toxicity	ISO 10993-11	Pass	Pass	Same

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Chemical Permeation / Chemotherapy Testing
Resistance to	ASTM	Carmustine andThiotepa haveextremely lowpermeation times of	Carmustine andThiotepa haveextremely lowpermeation timesof less than 30
Permeation	D6978-05	less than 30 minutes	minutes	Same

9. Conclusion

Based on intended use, technological characteristics and Non-Clinical performance data, the subject device; BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12", POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM is substantially equivalent to the predicate device K081089 - Kimberly-Clark STERLING* Nitrile & STERLING* NITRILE-EXTRA Powder-Free Exam Gloves with Chemotherapy Drug Use Claim.

Based on intended uses, technological characteristics and non-clinical performance data, the subject device is substantially equivalent to the predicate device K081089 - Kimberly-Clark STERLING* Nitrile & STERLING* NITRILE-EXTRA Powder-Free Exam Gloves with Chemotherapy Drug Use Claim.

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

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

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.