EXAMINATION GLOVE (POWDERED) IS A DISPOSABLE DEVICE MADE OF NATURAL LATEX INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINERS HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER AND IS POWDERED WITH A DONNING POWDER ABSORBABLE USP CORN STARCH.

Device Description

Class I Patient Examination Gloves (powdered) 80L that meets all 'the requirements of ASTM D3578.

AI/ML Overview

Here's the breakdown of the acceptance criteria and study information for the Latex Examination Gloves (Powdered) from Brightway Gloves Pvt. Ltd., as extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristics	SIZE	Acceptance Criteria (ASTM D3578)	Reported Performance (BGPL Value)	Meets Criteria?
Length	EX-S	220 mm minimum	235-240 mm	Yes
	S	220 mm minimum	235-240 mm	Yes
	M	230 mm minimum	235-240 mm	Yes
	L	230 mm minimum	235-240 mm	Yes
Width	EX S	70 +/- 6 mm	70 mm	Yes
	S	80 +/- 6 mm	82 mm	Yes
	M	95 +/- 6 mm	93 mm	Yes
	L	111 +/- 6 mm	107 mm	Yes
Thickness	EX S	0.08 mm minimum	0.10 mm	Yes
	S	0.08 mm minimum	0.10 mm	Yes
	M	0.08 mm minimum	0.10 mm	Yes
	L	0.08 mm minimum	0.10 mm	Yes
Tensile Strength (Before Ageing)	N/A	14 mpa min	20 - 22 mpa	Yes
Elongation at break % (Before Ageing)	N/A	700% min	800 - 850%	Yes
Tensile Strength (After Ageing)	N/A	14 mpa min	18 – 20 mpa	Yes
Elongation at break % (After Ageing)	N/A	500% min	750-800%	Yes
Freedom from Holes (AQL)	N/A	4	1.5 (Reported as 'followed by BGPL', lower AQL is better)	Yes
Dimension (AQL)	N/A	4	4	Yes
Physical Property (AQL)	N/A	4	4	Yes
Powder Content	N/A	Not explicitly stated in table, but noted in "Conclusion"	120 +/- 20 mg per glove	Yes (implied by conclusion)
Protein Content	N/A	Not explicitly stated in table, but noted in "Conclusion"	80 +/- 20 ppm	Yes (implied by conclusion)
Moisture Content	N/A	Not explicitly stated in table, but noted in "Conclusion"	0.8% max	Yes (implied by conclusion)
Biocompatibility	N/A	Not explicitly stated in table, but noted in "Conclusion"	Biologically Compatible	Yes (implied by conclusion)
Pin hole Requirement	N/A	FDA Pin hole Requirement	Not explicitly quantified, but stated "Meet FDA Pin hole Requirement"	Yes

Note: For characteristics like Powder Content, Protein Content, Moisture Content, and Biocompatibility, no specific ASTM D3578 numerical requirement was explicitly listed in the tables provided for direct comparison. However, the "Conclusion of Performance Test Data" explicitly states that the gloves "Meet or exceed the ASTM D3578" and "Meet FDA Pin hole Requirement" and "Meet labelling claim," implying that the stated performance values for these attributes align with the relevant standards.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample size used for the test set for each parameter. It lists the measured values for various glove sizes and properties. The data provenance is from India (manufacturer is M/s. BRIGHTWAY GLOVES PVT.LTD. in Tamil Nadu, India). The study appears to be retrospective in the sense that it presents the results of tests already conducted (e.g., "The performance test data... given below").

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

N/A. This is a medical device (patient examination gloves) that is evaluated against established technical standards (ASTM D3578) and regulatory requirements (FDA pinhole requirement). The ground truth is objective measurement data against these standards, not expert interpretation of subjective information.

4. Adjudication Method for the Test Set

N/A. As mentioned above, the determination is based on objective measurements against predefined standards, not subjective assessments requiring adjudication among experts.

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

N/A. This is a physical medical device (gloves), not an AI-powered diagnostic or interpretive system that would involve human readers or AI assistance.

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

N/A. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The ground truth used for this device is based on established industry standards and regulatory requirements, specifically:

ASTM D3578 (Standard Specification for Rubber Examination Gloves)
FDA Pinhole Requirement

These provide objective benchmarks for physical, chemical, and performance properties.

8. The sample size for the training set

N/A. This is a physical medical device. The concept of a "training set" is relevant for AI algorithms, not for the manufacturing and testing of examination gloves. The product undergoes quality control and testing against specifications, not machine learning model training.

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

N/A. As above, the concept of a "training set" and its ground truth establishment is not applicable to this type of device.

Summary

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PAGE NO: 50

1.0. 510K SUMMARY as required by: 807.92(c)

2.0 APPLICANT	K014280 MAR 2 0 2002
NAME	M/s. BRIGHTWAY GLOVES PVT.LTD.
ADDRESS	PIONEER MANIKANDAN BUILDINGS VADASERY, NAGERCOIL, TAMILNADU, INDIA-629001.
PH.NO.	91-4652-276046, 276291
FAX NO	91-4652-274271.
CONTACT PERSON	MR. N. PARAMASIVAN MANAGING DIRECTOR.
3. DEVICE TRADE NAME	: NIL
COMMON NAME	: Patient Examination Glove (powdered)

1. Legally marketed device to which the company claiming equivalence: Class I Patient Examination Gloves (powdered) 80LYY that meets all the requirements of ASTM D3578 .

5. DESCRIPTION OF THE DEVICE:

Class I Patient Examination Gloves (powdered) 80L that meets all 'the requirements of ASTM D3578.

Intended use of the Device:

Latex Examination glove (powdered) is a disposable device made of Natural Latex intended for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner and is powdered with a donning powder absorbable USP corn starch.

Image /page/0/Picture/8 description: The image is a circular seal with the words 'BRIGHTWAY GLOVES PVT. LTD.' around the outer edge. Inside the circle is the word 'NAGERCOIL' in bold, block letters. A five-pointed star is at the bottom of the seal.

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7.0 TECHNOLOGICAL CHARACTERSTICS OF THE DEVICE COMAPARED TO PREDICATE DEVICE.

Measured Parameters ofExamination gloves (powdered)manufactured by Brightway Gloves			ASTM D3578Requirement forExamination glove(powdered)
Characteristics	SIZE	Value
1. Length	EX-S	235-240 mm	220 mm minimum
	S	235-240 mm	220 mm minimum
	M	235-240 mm	230 mm minimum
	L	235-240 mm	230mm minimum
2. Width	EX S	70MM	70 +/- 6 mm
	S	82 mm	80 +/- 6 mm
	M	93 mm	95 +/- 6 mm
	L	107 mm	111+/- 6mm
3. Thickness	EX S	0.10mm	0.08 mm minimum
	S	0.10mm	0.08 mm minimum
	M	0.10mm	0.08 mm minimum
	L	0.10mm	0.08 mm minimum

PHYSICAL PROPERTIES

	BEFORE AGEING		AFTER AGEING
CHARACTERISTICS	BGPL VALUE *	ASTD 3578REQUIREMENT	BGPL VALUE	ASTD 3578Requirement
Tensile Strength	20 - 22 mpa	14 mpa min	18 – 20 mpa	14 mpa min
Elongation at break %	800 - 850%	700% min	750-800%	500% min

BGPL -- BRIGHTWAY GLOVES PVT.LTD.

and the control of the state

Image /page/1/Picture/6 description: The image shows a circular stamp with the words "BRIGHTWAY GLOVES PVT. LTD." around the outer edge. In the center of the stamp, the word "NAGERCOIL" is printed. A five-pointed star is located at the bottom of the stamp.

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PERFORMANCE REQUIREMENT:

Characteristics	Related defects	Level followedBy		AQLfollowed byBGPL	AQL Value asper ASTMD3578.
		BGPL	As perASTMD3578
Freedom fromHoles	Holes	S4	S4	1.5	4
Dimension	Width , LengthThickness.	S2	S2	4	4
PhysicalProperty	TensileStrength,Elongation atBreak.	S2	S2	4	4

POWDER CONTENT

.DAT TITT	THE THE THE FEATURE FOR
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PROTEIN CONTENT:

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MOISTURE CONTENT:

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BIOCOMPATIBLITY:

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8.0 Performance Data:

The performance test data of the Latex Examination Glove (powdered) manufactured by Brightway Gloves Pvt.Ltd given below.

Measured Parameters ofExamination gloves (powdered)manufactured by Brightway Gloves Pvt.Ltd.,
Characteristics	SIZE	Value
1. Length	EX-S	235-240 mm
	S	235-240 mm
	M	235-240 mm
	L	235-240 mm
2. Width	EX S	70MM
	S	82 mm
	M	93 mm
	L	107 mm
3. Thickness	EX S	0.10mm
	S	0.10mm
	M	0.10mm
	L	0.10mm

PHYSICAL PROPERTIES

DICITICA
A 914	11.02
Elongation at break %	MARKER FREE LE LE LE LEBERT --------------------------------------------------------------------------------------------------------------------------------------------------	2000/

INSPECTION LEVEL AND AQL:

Characteristics	Related defects	Level	AQL
Freedom fromHoles	Holes	S4	1.5
Dimension	Width , LengthThickness.	S2'	4
PhysicalProperty	TensileStrength,Elongation atBreak.	S2	4

Image /page/3/Picture/8 description: The image is a circular stamp with the words "BRIGHTWAY GLOVES PVT. LTD." written around the border of the circle. Inside the circle, the word "NAGERCOIL" is written in bold letters. A five-pointed star is located at the bottom of the circle.

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POWDER CONTENT: 120 +/- 20 mg per glove

PROTEIN CONTENT: 80 +/- 20 ppm

MOISTURE CONTENT: .0.8% max

BIOCOMPATIBILITY: Biologically Compatible.

Clinical Data : NA

CONCLUSION OF PERFORMANCE TEST DATA: 10.

The Examination gloves (powdered) manufactured by M/S Brightway Gloves Pvt.Ltd,

. . Meet or exceed the ASTM D3578

Meet FDA Pin hole Requirement. -
Meet labelling claim as shown by the data in 6 -

11. ANY OTHER INFORMATION:

Any other information required by FDA regarding product safety and effectiveness will be provided on request.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 0 2002

Mr. N. Paramasivan Managing Director Brightway Gloves PVT. LTD. Pioneer Manikandan Building Vadasery, Nagar Coil, Tamil Nadu, INDIA

Re: K014280

Trade/Device Name: Latex Examination Gloves (Powdered) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: December 27, 2001 Received: December 27, 2001

Dear Mr. Paramasivan:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. Paramasivan

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DUPLICATE

K 014280/A'

Page ol

510(k) NUMBER (IF KNOWN0014280 (

DEVICE NAME LATEX-EXANTHATION GLOVES (FOMDERED)

INDICATIONS FOR USE:

EXAMINATION GLOVE (POWDERED) IS A DISPOSABLE DEVICE LATEX MEDICAL PURPOSE THAT IS NATURAL LATEX INTENDED FOR MADE OF WORN ON THE EXAMINERS HAND OR FINGER TO PREVENT CONTAMINATION AND TO PAWDEREA WITH ARSANAAAFF BETWEEN PATIENT AND EXAMINER DUSTING POWDER USP CORN STARCH.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

ાર

Over-The-Counter-Use (Optional Format 1-2-96)

Chiu S. Lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number _

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.