K Number

Device Name

LATEX SURGEONS GLOVE (POWDERED)

Manufacturer

BRIGHTWAY GLOVES PVT. LTD.

Date Cleared

2002-05-14

(138 days)

Product Code

KGO

Regulation Number

878.4460

Intended Use

Surgeon's glove (powdered) is a sterile medical device made of natural latex intended to be worn by operating room personnel to protect a surgical wound from contamination and is powdered with absorbable dusting powder USP corn starch as the donning lubricant.

Device Description

Class I Powdered Surgical Glove 79KGO that meets all the requirements of ASTM D3577.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

79KGO

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a standard surgical glove and the summary contains no mention of AI or ML capabilities.

Therapeutic

No
The device is described as a surgical glove intended to protect a surgical wound from contamination, which is a protective rather than therapeutic function.

Diagnostic

The "Intended Use" states that the device is a "sterile medical device... intended to be worn by operating room personnel to protect a surgical wound from contamination," which describes a protective barrier, not a diagnostic tool.

SaMD (Software as a Medical Device)

The device is a physical surgical glove made of latex, not a software application. The description focuses on physical properties and performance characteristics of the glove.

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 by operating room personnel to protect a surgical wound from contamination. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body) on specimens.
Device Description: It's described as a Class I Powdered Surgical Glove. Surgical gloves are medical devices used for protection and hygiene during procedures, not for diagnosing conditions.
Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing information for diagnosis, monitoring, or screening

The performance data provided relates to the physical properties and integrity of the glove (length, width, thickness, tensile strength, freedom from holes, etc.), which are relevant to its function as a protective barrier, not as a diagnostic tool.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Powdered Surgeon's glove is a sterile Medical Device intended tobe worn by Operating room personnel to protect a surgical wound from contamination and is powdered with a absorbable dusting powder USP corn starch as a donning Lubricant.
Surgeon's glove (powdered) is a sterile medical device made of natural latex intended to be worn by operating room personnel to protect a surgical wound from contamination and is powdered with absorbable dusting powder USP corn starch as the donning lubricant.

Product codes

KGO

Device Description

Class I Powdered Surgical Glove 79KGO that meets all 'the requirements of ASTM D3577.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Operating room personnel / surgical wound

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)

The performance test data of the powdered surgical gloves manufactured by Brightway Gloves Pvt.Ltd is given below.
Measured Parameters of Latex Surgeon's gloves (Powdered) manufactured by Brightway Gloves Pvt.Ltd., Characteristics:

Length: 5 ½ (270-272 mm), 6 (270-272 mm), 6 ½ (270-272 mm), 7 (270-272 mm), 7 ½ (270-272 mm), 8 (270-272 mm), 8 ½ (270-272 mm), 9 (270-272 mm)
Width: 5 ½ (68 mm), 6 (73 mm), 6 ½ (79 mm), 7 (87 mm), 7 ½ (92 mm), 8 (103 mm), 8 ½ (106 mm), 9 (112 mm)
Thickness at cuff, Palm and finger tip of all the size is 0 .12, 0.16 and 0.19 mm.

PHYSICAL PROPERTIES:
Before Ageing: Tensile Strength (27 mpa), Elongation at break % (850%), Modulus at 500 % elongation (3 mpa)
After Ageing: Tensile Strength (20 mpa), Elongation at break % (750%), Modulus at 500 % elongation (Not provided)

PERFORMANCE REQUIREMENT:
Sterility: Fails sterility, LEVEL As per Indian Pharmacopeias, AQL Not Found
Freedom from Holes: Holes, LEVEL S4, AQL 1.5
Dimension: Width, Length, Thickness., LEVEL S2, AQL 4
Physical Property: Tensile strength, Elongation at break before and after ageing., LEVEL S2, AQL 4

POWDER CONTENT: 120 + /- 20 mg per Glove
PROTEIN CONTENT: 80 +/- 20 ppm
MOISTURE CONTENT: 0.8 % max
BIOCOMPATABILITY: Biologically Compatible

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Class I Surgeon's Glove ( Powdered) 79KGO that meets all the requirements of ASTM D3577.

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 878.4460 Non-powdered surgeon's glove.

(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).

Summary

MAY 1 4 2002

PAGE NO : 70

510K SUMMARY as required by: 807.92(c)

K014278

1.0 APPLICANT

NAME	: BRIGHTWAY GLOVES PVT.LTD
ADDRESS	: PIONEER MANIKANDAN BUILDINGS,
VADASERY
NAGAR COIL,
TAMIL NADU,
INDIA – 629001.
PH.NO.	: 91-4652-276291, 276046.
FAX NO	: 91-4652-274271

CONTACT PERSON : N. PARAMASIVAN : MANAGING DIRECTOR

1. DEVICE TRADE NAME : NIL
  COMMON NAME : Surgeon's Glove

: Surgeon's Glove (powdered) Classification Name

1. Legally marketed device to which the company claiming equivalence: Class I Surgeon's Glove ( Powdered) 79KGOthat meets all the requirements of ASTM D3577.
1. DESCRIPTION OF THE DEVICE :

Class I Powdered Surgical Glove 79KGO that meets all 'the requirements of ASTM D3577.

6.0 Intended use of the Device:

Image /page/0/Picture/15 description: The image is a circular stamp with the words "BRIGHTWAY GLOVES PVT. LTD." written around the edge of the circle. In the center of the circle, the word "NAGERCOIL" is written in large, bold letters. There is a five-pointed star at the bottom of the circle.

PAGE NO : 71

7.0 Technological characteristics of the device compared to predicate device.

			ASTM D3577
Measured Parameters of Latex			Requirement for
Surgeon's gloves (Powdered)
manufactured by Brightway Gloves			Latex Surgeon's glove
(Powder free)
Pvt.Ltd
Characteristics	SIZE	Value
1. Length	5 ½	270-272 mm	245 mm minimum
	6	270 - 272 mm	265 mm minimum
	6 ½	270 - 272 mm	265 mm minimum
	7	270 - 272 mm	265mm minimum
	7 ½	270 –272 mm	265 mm minimum
	8	270 –272 mm	265 mm minimum
	8 ½	270 - 272 mm	265 mm minimum
	9	270 – 272 mm	265 mm minimum
2. Width	5 ½	68 mm	70 +/- 6 mm
	6	73mm	76 +/- 6mm
	6 ½	79mm	83 +/- 6 mm
	7	87mm	99 +/- 6 mm
	7 ½	92mm	95 +/- 6 mm
	8	103mm	105 +/- 6 mm
	8 ½	106mm	108 +/- 6 mm
	9	112mm	114 +/- 6 mm

1. Thickness at cuff , Palm and finger tip of all the size is 0 .12, 0 .16 and 0.19mm.
  ASTM D3577 requirement for thickness at cuff, palm and finger tip is 0.1 mm minimum.

PHYSICAL PROPERTIES:

	BEFORE AGEING		AFTER AGEING
Characteristics	*BGPL Value	ASTM
D3577
Requirement	BGPL Value	ASTM
D3577
Requirement
Tensile Strength	27 mpa	24 mpa	20 mpa	18 mpa min
Elongation at break %	850%	750%	750%	560% min
Modulus at 500 %
elongation.	3 mpa	5.5 mpa
(max)	-	-

. . .

*Brightway Gloves Pvt.Ltd

Image /page/1/Picture/8 description: The image is a circular stamp with the words "BRIGHTWAY GLOVES PVT. LTD." written around the edge. In the center of the stamp, the word "NAGERCOIL" is written in bold letters. There is a small star-like symbol at the bottom of the stamp. The stamp appears to be slightly faded or worn, giving it a vintage look.

PAGE NO : 72

PERFORMANCE REQUIREMENT:
Characteristics	Related defects	Level followed By
BGPL	Level As per ASTM D 3577	AQL followed By BGPL	AQL as per ASTM D3577.
Sterility	Fails sterility	As per IP*	As per USP*.	NA	NA
Freedom from Holes	Holes	S4	S4	1.5	1.5
Dimension	Width,
Length
Thickness.	S2	S2	4	4
Physical Property	Tensile strength,
Elongation at break before
and after ageing.	S2	S2	4	4

IP – INDIAN PHARMACOPEA

POWDER CONTENT

| The for the management of the comments of the comments of the comments of the first and the first and the first and
BGPL VALUE | The First of the first of the country of the country of the first of the first of the first of the first of the first of the first of the first of the first of the first of t
ASTM REQUIREMENT
The Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The program to Apr 1 a Martin Comments of Act A Comments of Act A Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Com | l 150 mg/glove max on Medium size |
| 120+/- 20 mg on size 8 | Comment of the consistent of the comments of the production of the comments of the comments of the comments of |

PROTEIN CONTENT:

BGPL VALUE	FDA REQUIREMENT
80 +/- 20 ppm	200 ppm (max)

MOISTURE CONTENT:

| BGPL VALUE | A BRIDGE CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CON
FDA REQUIREMENT |
|------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 0.8% max | No value fixed
LEL LEARNER BERESS - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - |

BIOCOMPATIBILITY:

BGPL GLOVE	FDA REQUIREMENT
Biologically Compatible
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Biologically Compatible

Image /page/2/Picture/11 description: The image shows a circular stamp with the words "BRIGHTWAY GLOVES PVT. LTD." around the outer edge. Inside the circle, the word "NAGERCOIL" is printed in bold, uppercase letters. The stamp appears to be slightly smudged, giving it a worn or used look.

8.0. Performance Data:

The performance test data of the powdered surgical gloves manufactured by Brightway Gloves Pvt.Ltd is given below.

Measured Parameters of Latex
Surgeon's gloves (Powdered)
manufactured by Brightway Gloves
Pvt.Ltd.,
Characteristics	SIZE	Value
1. Length	5 ½	270-272 mm
	6	270-272 mm
	6 ½	270-272 mm
	7	270-272 mm
	7 ½	270-272 mm
	8	270-272 mm
	8 ½	270-272 mm
	9	270-272 mm
2. Width	5 ½	68 mm
	6	73 mm
	6 ½	79 mm
	7	87 mm
	7 ½	92 mm
	8	103 mm
	8 ½	106 mm
	9	112 mm

1. Thickness at cuff , Palm and finger tip of all the size is 0 .12, 0.16 and 0.19 mm.

PHYSICAL PROPERTIES:

Characteristics	Before Ageing	After Ageing
Tensile Strength	27 mpa	20 mpa
Elongation at break %	850%	750%
Modulus at 500 %
elongation.	3 mpa	-

Image /page/3/Picture/7 description: The image is a circular stamp with the words "BRIGHTWAY GLOVES PVT. LTD." around the border. In the center of the stamp is the word "NAGERCOIL" in a bold, sans-serif font. The stamp appears to be somewhat faded or worn, giving it a vintage look.

PERFORMANCE REQUIREMENT:

| Characteristics | Related
defects | LEVEL | AQL |
|-----------------------|-------------------------------------------------------------------------------|--------------------------------|-----|
| Sterility | Fails sterility | As per Indian
Pharmacopeias | |
| Freedom from
Holes | Holes | S4 | 1.5 |
| Dimension | Width ,
Length
Thickness. | S2 | 4 |
| Physical
Property | Tensile
strength,
Elongation at
break before
and after
ageing. | S2 | 4 |

POWDER CONTENT: 120 + /- 20 mg per Glove

PROTEIN CONTENT: 80 +/- 20 ppm

MOISTURE CONTENT: 0.8 % max

BIOCOMPATABILITY: Biologically Compatible

。

Clinical Data

CONCLUSION OF PERFORMANCE TEST DATA:

The Powdered Surgeon's gloves manufactured by Brightway Gloves Pvt Ltd

-Meet or exceed the ASTM D3577
Meet FDA Pin hole Requirement. -
Meet labeling 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.

Image /page/4/Picture/16 description: The image shows a circular stamp with the words "BRIGHTWAY GLOVES PVT. LTD." around the outer edge. Inside the circle is the word "NAGERCOIL" in a smaller circle. There is a star at the bottom of the stamp.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. N. Paramasivan Managing Director Brightway Gloves PVT. LTD. Pioneer Manikandan Buildings Vadasery, Nagar Coil Tamil Nadu. INDIA 629001

Re: K014278

Trade/Device Name: Sterile Latex Surgeon's Glove, Powdered Regulation Number: 878.4460 Regulation Name: Surgeon's Gloves Regulatory Class: I Product Code: KGO Dated: March 23, 2002 Received: April 11, 2002

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.

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 ail 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runge

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

Enclosure

PAGE NO : 3

INDICATIONS FOR USE: 3.0

BRIGHTWAY GLOVES PVT.LTD. APPLICANT . Ko14278 : 510(K) No. LATEX SURGEON'S GLOVE POWDERED DEVICE NAME

INDICATIONS FOR USE:

Sunge

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ 8014279

Image /page/7/Picture/7 description: The image is a circular stamp with the words "OR HIGHWAY GLOVES PVT. LTD." around the perimeter of the circle. Inside the circle is the word "HAGERCOIL" in block letters. The stamp appears to be slightly faded or worn, giving it a vintage look. The text is all in uppercase.