Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical and chemical properties of examination gloves, with no mention of AI or ML technologies.

Therapeutic

No
The device is described as an examination glove intended to prevent contamination, functioning as a barrier, not to treat or cure a disease or condition.

Diagnostic

No

Explanation: The device is described as an examination glove intended to prevent contamination between patient and examiner, functioning as a barrier. Its purpose is not to diagnose any condition.

SaMD (Software as a Medical Device)

No

The device is a physical examination glove made of nitrile, not software. The description focuses on material properties and physical performance tests.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "to be worn on the examiners hand or finger to prevent contamination between patient and examiner." This describes a barrier device for personal protection and infection control, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or screening.
Device Description: The description focuses on the physical properties and barrier function of the glove, not on any diagnostic capabilities or interaction with biological samples for analysis.
Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information. The performance studies focus on the physical integrity and biocompatibility of the glove.

Therefore, this device falls under the category of a medical device, specifically an examination glove, but not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [LAVENDER] is a disposable device intended for medical purpose, to be worn on the examiners hand or finger to prevent contamination between patient and examiner.

Product codes

LZA

Device Description

The subject device is a patient examination glove made from a Nitrile compound, Lavender 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 that 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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hand or finger

Indicated Patient Age Range

Not Found

Intended User / Care Setting

examiner

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Dimension and Thickness of Gloves Dimension Measurement & Water Tight Test Report

Test Method: ASTM D6319-10
Sample Tested: 20 pieces per Batch Random Sumpling based on ISO2859-1:1999; S2 AQL 2.5, Ac=1 Rej=2
Key Results: All samples passed the dimension measurement specifications for weight, length, width, and thickness (finger tip, palm, cuff).

Water-tight Test

Test method: ASTM D5151
Sample tested: 200 pieces per Batch. Random Sampling based on 1502859-1:1999; G2 AQL 1.5, Ac=7 Rej=8
Key Results: The total number of defective gloves was 1 (from palm region for X-Small size), which was within the acceptance number of 7 for that batch, resulting in a "Pass" status for the batch.

Physical Properties Analysis Report

Test Method: ASTM D 6319 - 10
Sample Plan: Single Normal S2 AQL: 2.5 Acc/Rej : 1/2.
Sizes Comprising Of: XS, S, M, L & XL
Aging: 70 +/- 2 deg C for 168 Hrs.
Key Results: The gloves met all the specifications listed in ASTM D 6319-10 for Modulus at 500%, Tensile Strength (before and after aging), and Ultimate Elongation (before and after aging).

Biocompatibility tests

Tests performed: Primary Skin Irritation test (ISO 10993-10), Dermal sensitization assay (ISO 10993-10), Systemic Toxicity (ISO 10993-11).
Key Results: The gloves were non-sensitizing, non-irritating, and non-systemically toxic under the conditions of the studies.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K081260 KIMBERLY-CLARK* LAVENDER* NITRILE Powder-Free Exam Gloves

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol consists of three human profiles facing right, stacked on top of each other, with flowing lines extending from the bottom profile.

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

January 5, 2017

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

Re: K162146

Trade/Device Name: Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: July 19, 2016 Received: August 1, 2016

Dear Dr. 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

1

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 the quality systems (QS) 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.

Sincerelv.

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

2

Indications for Use

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

510(k) Number (if known) K162146

Device Name

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [LAVENDER]

Indications for Use (Describe)

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [LAVENDER] is a disposable device intended for medical purpose, to be worn on the examiners hand or finger to prevent contamination between patient and examiner.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

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510(K) SUMMARY

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [LAVENDER]

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

4th January 2017 2. Preparation Date :
1. Name of the Device :

Device trade or proprietary name: BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [LAVENDER]

4

Device Classification Name: Patient Examination Glove

(21 CFR 880.6250)

Device common or usual name: NITRILE EXAMINATION GLOVE

FDA Device Class : Class 1

Product Code : LZA

1. Identification of the Device :
  Class I patient Examination Nitrile gloves, Powder Free, LZA, 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:

1. K081260 KIMBERLY-CLARK* LAVENDER* NITRILE Powder-Free Exam Gloves

5. Device Description :

The subject device in this 510(k) Notification is a Lavender Examination Glove.

The subject device is a patient examination glove made from a Nitrile compound, Lavender 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 that 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

5

6. Intended use of the Device

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [LAVENDER] is a disposable device intended for medical purpose, to be worn on the examiners hand or finger to prevent contamination between patient and examiner.

7. Specification For Nitrile gloves

7.1. Dimension and Thickness of Gloves Dimension Measurement & Water Tight Test Report

Certificate No : 6G11 01

Date : 11/07/2016

: Lavender Nitrile Exam Glove. Brand

Prd Description : Brightway Brand Nitrile Examination Gloves, Powder Free [Lavender]

Standard Specification for Nitrile Examination Gloves for Medical Application Test Method: ASTM D6319-10

Dimension Measurement

Test Method: ASTM D6319-10

Sample tested: 20 pieces per Batch Random Sumpling based on ISO2859-1:1999; S2 AQL 2.5, Ac=1 Rej=2

Batch No: 6G02 01

Sample No.	Size	Weight (g)	Length (mm)	Width (mm)	Thickness (mm)
					Finger Tip	Palm	Cuff
1	XS	2.8	243	78	0.095	0.065	0.055
2	XS	2.7	240	77	0.090	0.070	0.055
3	XS	2.8	243	78	0.090	0.075	0.06
4	XS	2.9	242	77	0.095	0.065	0.055
5	S	3.1	243	84	0.090	0.070	0.055
6	S	3.0	241	85	0.095	0.070	0.06
7	S	3.0	242	83	0.090	0.075	0.055
8	S	2.9	243	84	0.095	0.065	0.06
9	M	3.1	241	97	0.095	0.065	0.065
10	M	3.3	242	98	0.10	0.070	0.06
11	M	3.2	242	97	0.095	0.070	0.055
12	M	3.1	243	98	0.095	0.075	0.06
13	L	3.9	243	114	0.090	0.065	0.065
14	L	3.8	241	112	0.10	0.070	0.055
15	L	3.7	242	112	0.095	0.075	0.06
16	L	3.8	243	113	0.095	0.070	0.055
17	XL	4.1	242	121	0.090	0.065	0.055
18	XL	4.0	241	120	0.090	0.070	0.06
19	XL	4.0	242	121	0.095	0.075	0.06
20	XL	4.1	243	120	0.090	0.070	0.06
Specification For XS		$2.7 \pm 0.3g$	Min - 230
Tar - 240
Max - 258	Min - 60
Tar - 70
Max - 80	Min - 0.06
Tar - 0.08
Max - 0.11	Min - 0.05
Tar - 0.07
Max - 0.09	Min - 0.05
Tar - 0.06
Max - 0.08
Specification For Small		$2.9 \pm 0.3g$	Min - 230
Tar - 240
Max - 258	Min - 70
Tar - 80
Max - 90	Min - 0.06
Tar - 0.08
Max - 0.11	Min - 0.05
Tar - 0.07
Max - 0.09	Min - 0.05
Tar - 0.06
Max - 0.08
Specification For Medium		$3.2 \pm 0.3g$	Min - 230
Tar - 240
Max - 258	Min - 85
Tar - 95
Max - 105	Min - 0.06
Tar - 0.08
Max - 0.11	Min - 0.05
Tar - 0.07
Max - 0.09	Min - 0.05
Tar - 0.06
Max - 0.08
Specification For Large		$3.8 \pm 0.3g$	Min - 230
Tar - 240
Max - 258	Min - 100
Tar - 110
Max - 120	Min - 0.06
Tar - 0.08
Max - 0.11	Min - 0.05
Tar - 0.07
Max - 0.09	Min - 0.05
Tar - 0.06
Max - 0.08
Specification For XL		$4.0 \pm 0.3g$	Min - 230
Tar - 240
Max - 258	Min - 110
Tar - 120
Max - 130	Min - 0.06
Tar - 0.08
Max - 0.11	Min - 0.05
Tar - 0.07
Max - 0.09	Min - 0.05
Tar - 0.06
Max - 0.08
Number of non-conformance		0	0	0	0	0	0
Status		Pass	Pass	Pass	Pass	Pass	Pass

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7.2. Gloves Physical Properties and Freedom From Holes

Water-tight Test

Test method: ASTM D5151

Sample tested: 200 pieces per Batch.

Random Sampling based on 1502859-1:1999; G2 AQL 1.5, Ac=7 Rej=8

Location of holes	Size : X - Small	Size : Small	Size : Medium	Size : Large	Size : X - Large
Cuff	0	0	1	0	0
Palm	2	0	0	0	0
Finger-tip	0	0	0	0	0
Total defective Found	1
Acceptance number	7
Status	Pass

BRIGHTWAY HOLDINGS SDN BF

Testing Services

Physical Properties Analysis Report

Certificate No	:	6G11 25
Customer	:	N/A
Brand	:	LAVENDER NITRILE EXAM GLOVES
PO No	:	N/A
PI No	:	N/A
Batch No	:	6G02 01
Product Description	:	Brightway Brand Nitrile Examination Gloves, Powder Free
[Lavender]
Sample Receiving Date	:	03.07.2016
Sampling Plan	:	Single Normal S2 AQL: 2.5 Acc/Rej : 1/2 .
Sizes Comprising Of	:	XS, S, M, L & XL
Test Method	:	ASTM D 6319 - 10
Test Conducted on	:	10/07/2016
Aging	:	70 +/- 2 deg C for 168 Hrs .

| Test Environment
Condition | RH (%)
: 48 | | RH (%)
: 48 | |-------------------------------|-- | | | Sample
No | Size At 500%
(MPa) | Tensile
Strength
(MPa) | Ultimate
Elongation
(%) | Tensile
Strength
(MPa) | Ultimate
Elongation
(%) |
| 1 | XS | 2 | XS | 3 | XS | 4 | XS | 5 | S | 6 | S | 7 | S | 8 | S | 9 | M | 10 | M | 11 | M | 12 | M | 13 | L | 14 | L | 15 | L | 16 | L | 17 | XL | 18 | XL | 19 | XL | 20 | XL | | | Room Temperature (°C) : 23
| Room Temperature (°C) : 23
|
-----------------|----------------------------------------------|------------------------------|-------------------------------|----------------------------------------------|-------------------------------|
| Before Aging | | | After Aging | |
| Modulus
| 18.9 | 26.125 | 592.6 | 27.412 | 510.6 |
| 19.5 | 27.986 | 561.7 | 26.322 | 529.4 |
| 17.9 | 29.632 | 578.8 | 25.879 | 492.5 |
| 18.2 | 26.231 | 592.3 | 27.653 | 503.7 |
| 19.5 | 27.588 | 581.6 | 26.968 | 536.9 |
| 17.4 | 29.451 | 559.2 | 25.121 | 511.6 |
| 18.3 | 28.212 | 563.5 | 27.454 | 507.8 |
| 19.2 | 26.102 | 586.4 | 26.958 | 498.8 |
| 18.9 | 27.877 | 577.3 | 25.525 | 522.9 |
| 17.7 | 29.636 | 591.6 | 24.118 | 537.7 |
| 19.2 | 26.096 | 554.2 | 25.412 | 542.3 |
| 18.9 | 27.741 | 596.8 | 26.589 | 519.2 |
| 17.5 | 26.655 | 583.7 | 26.470 | 507.3 |
| 18.6 | 28.825 | 573.1 | 27.965 | 544.9 |
| 19.4 | 29.821 | 565.8 | 25.231 | 520.5 |
| 17.6 | 26.644 | 680.4 | 26.598 | 518.1 |
| 18.2 | 27.132 | 593.2 | 27.415 | 502.6 |
| 19.5 | 29.990 | 570.8 | 24.626 | 533.8 |
| 19.2 | 26.512 | 588.9 | 26.118 | 510.7 |
| 18.4 | 27.849 | 591.6 | 25.956 | 546.4 |
| Average Result | 18.6 | 27.805 | 588.8 | 26.075 | 523.5 |
| Cust. Requirement | N/A | 16 (Min) | 500 (Min) | 15(Min) | 450 (Min) |

Gloves meet all the specification listed in ASTM D 6319-10

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1. 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

Summary of Technical Characteristics and Substantial Equivalence Compared to Predicate Device :

The predicate device in scope is as follows

1. K081260 KlMBERLY-CLARK* LAVENDER* NITRILE Powder-Free Exam Gloves
  BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [LAVENDER] is substantially equivalent in safety and effectiveness to K081260 -KIMBERLY-CLARK* LAVENDER* NITRILE Powder-Free Exam Gloves

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	Standard	Device Performance
		Predicate Device :
K081260 -
Kimberly Clark*
Lavender*
Nitrile Powder
Free
Examination
Glove	Subject Device :
K162146 -
BRIGHTWAY
BRAND NITRILE
EXAMINATION
GLOVES, POWDER
FREE, [LAVENDER]	Result of
Comparison
Labeling	N/A	There are no
special labeling
claims and do not
claim gloves as
hypoallergenic on
labels. No shelf life
claim.	There are no special
labeling claims and
do not claim gloves
as hypoallergenic on
labels. No shelf life
claim.	Same
Device Materials	N/A	Nitrile Compound	Nitrile Compound	Same
Colour	N/A	Lavender	Lavender	Same
Device Tolerances and Specifications & Performance Data
Tensile strength:
before and after
ageing	ASTM 6319-10	Meets
requirements	Meets requirements	Same
Ultimate Elongation :
Before and after
ageing	ASTM 6319-10	Meets
requirements	Meets requirements	Same
Freedom from
Pinholes	ASTM 6319-10	Meets
requirements	Meets requirements	Same
Dimensions:	ASTM 6319-10,
ASTM 6319-10	Meets
requirements	Meets requirements	Same
Residual Powder :	ASTM D6124	Meets
requirements	Meets requirements	Same
Biocompatibility
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
contact sensitizer	Under conditions of
the study, not a
contact sensitizer	Same
Systemic Toxicity	ISO 10993-11	Non-systemically
toxic	Non-systemically
toxic	Same

8

9

12.0 Conclusion

Based on intended uses, technological characteristics and Non-Clinical performance data, the subject device; BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [LAVENDER] is substantially equivalent to the predicate device K081260 - KIMBERLY-CLARK* LAVENDER* NITRILE Powder-Free Exam Gloves.

Based on intended uses, technological characteristics and non-clinical performance data, the subject device is substantially equivalent to the predicate device K081260 - KlMBERLY-CLARK* LAVENDER* NITRILE Powder-Free Exam Gloves

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.

There are no safety/efficacy issues or new claims from the "substantial equivalence comparison" between the products cited.

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.