Nitrile Examination Glove is a disposable device made of Nitrile Latex intended for medi purpose, that is worn on the examiners hand or linger to prevent contamination between patie and Examiner.

Device Description

Class I Patient Examination (Floves ( Nitrile) 801 7.A that meets all 'the requirements of ASTM D3578- 95.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Nitrile Examination Glove, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristic	Acceptance Criteria (ASTM D3578 Requirement)	Reported Device Performance (Anusham Latex/SARI Value)
Length
EX-S	220 mm minimum	235-240 mm
S	220 mm minimum	235-240 mm
M	230 mm minimum	235-240 mm
L	230 mm minimum	235-240 mm
Width
EX S	70 +/- 6 mm	70MM
S	80 +/- 6 mm	82 mm
M	95 +/- 6 mm	93 mm
L	111 +/- 6 mm	107 mm
Thickness
EX S	0.08 mm minimum	0.10mm
S	0.08 mm minimum	0.10mm
M	0.08 mm minimum	0.10mm
L	0.08 mm minimum	0.10mm
Physical Properties (Before Ageing)
Tensile Strength	14 mpa min	18 - 20 mpa
Elongation at break %	700% min	750 - 800%
Physical Properties (After Ageing)
Tensile Strength	14 mpa min	16 - 18 mpa
Elongation at break %	500% min	650 - 700%
Performance Requirement: Freedom from Holes	AQL 4 (Level S4)	AQL 1.5 (Level S4)
Performance Requirement: Dimension	AQL 4 (Level S2)	AQL 4 (Level S2)
Performance Requirement: Physical Property	AQL 4 (Level S2)	AQL 4 (Level S2)
Powder Content	Not explicitly stated (implied by "AQL followed by SARI")	120 +/- 20 mg per glove
Protein Content	Not explicitly stated (implied by "AQL followed by SARI")	30 +/- 10 ppm
Moisture Content	Not explicitly stated (implied by "AQL followed by SARI")	0.8% max
Biocompatibility	Not explicitly stated (implied by "AQL followed by SARI")	Biologically Compatible

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

Sample Size: The document does not explicitly state the exact sample size used for the performance testing. It refers to "Measured Parameters of Examination gloves (Nitrile) manufactured by Anusham Latex" and "Performance test data of the Nitrile examination glove manufactured by Sri. Anusham Rubber Industries Pvt Ltd".
Data Provenance: The data is reported by M/s. SRLANUSHAM RUBBER INDUSTRIES PVT.LTD, located in TAMILNADU, INDIA. The data appears to be retrospective as it is presented as completed performance tests.

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 performance data is based on physical and chemical testing against ASTM standards, not expert human assessment.

4. Adjudication method for the test set:

This is not applicable as the evaluations are based on objective physical/chemical measurements against predefined standards (ASTM D3578) rather than subjective expert interpretation 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 information is not applicable. This document describes the performance characteristics of a physical medical device (examination gloves), not an AI-assisted diagnostic tool.

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

This is not applicable. This document describes the performance of a physical product.

7. The type of ground truth used:

The ground truth used for evaluating the device's performance is established industry standards and regulatory requirements, specifically:

ASTM D3578-95: "Standard Specification for Rubber Examination Gloves." This standard defines the physical property requirements for examination gloves.
FDA Pin Hole Requirement: A regulatory standard for barrier integrity.
Labelling claim: The device's performance against its own stated specifications.

8. The sample size for the training set:

This information is not applicable. This document describes a physical medical device, not a machine learning model that requires a training set.

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

This information is not applicable for the same reason as above.

Summary

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11/19/99

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

2.0 APPLICANT
---------------

NAME	M/s. SRLANUSHAM RUBBER INDUSTRIESPVT.LTD.
ADDRESS	PIONEER MANIKANDAN BUILDINGSVADASERY,NAGERCOIL,TAMILNADU,INDIA-629001.
PH.NO.	: 91-4652-33091,
FAX NO	: 91-4652-32871.
CONTACT PERSON	: MR. N. PARAMASIVANMANAGING DIRECTOR.
3. DEVICE TRADE NAME	: NIL
COMMON NAME	: Patient Examination Glove (Nitrile)

993347

1. Legally marketed device to which the company claiming equivalence: Class I Pationt Examination Gloves ( Nitrile) 80LZA that mects all the requirements of ASTM D3578 - 95.

5. DESCRIPTION OF THE DEVICE :

Class I Patient Examination (Floves ( Nitrile) 801 7.A that meets all 'the requirements of ASTM D3578- 95.

1. Intended use of the Device:
  Examination glove (Nitrile) is a disposable device made of Nitrile Latex intended for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner.

Image /page/0/Picture/10 description: The image shows a circular stamp with text around the perimeter. The text reads "SRI ARUSHAM RUBBER INDUSTRIES PVT. LTD." with a star symbol. In the center of the stamp, the text "NAGERCOIL" is vertically oriented.

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7.0 TECHNOLOGICAL CHARACTERSTICS OF THE DEVICE COMAPARED TO PREDICATE DEVICE.

Measured Parameters ofExamination gloves (Nitrile) manufacturedby Anusham Latex,			ASTM D3578Requirement forExamination glove(Nitrile)
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

CHARACTERISTICS	BEFORE AGEING		AFTER AGEING
	SARI VALUE *	ASTD 3578 REQUIREMENT	SARI VALUE	ASTD 3578 Requirement
Tensile Strength	18 - 20 mpa	14 mpa min	16 - 18 mpa	14 mpa min
Elongation at break %	750 - 800%	700% min	650-700%	500% min

SARI - SRLANUSHAM RUBBER INDUSTRIES .

Image /page/1/Picture/6 description: The image shows a circular stamp with text around the edges and in the center. The text around the edge reads "SRI ANUSHAM RUBBER INDUSTR. S PVT. LTD.", with a star on either side of the word LTD. In the center of the stamp, the text reads "NAGERCOIL" vertically.

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PERFORMANCE REQUIREMENT:

Characteristics	Related defects	Level followed By		AQL followed by SARI	AQL Value as per ASTM D3578.
		SARI	As per ASTM D3578
Freedom from Holes	Holes	S4	S4	1.5	4
Dimension	Width , Length Thickness.	S2	S2	4	4
Physical Property	Tensile Strength, Elongation at Break	S2	S2	4	4

POWDER CONTENT

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PROTEIN CONTENT:

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MOISTURE CONTENT:

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BIOCOMPATABILITY:

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Image /page/2/Picture/11 description: The image shows a circular stamp with text around the perimeter. The text includes "SRI ANUSHA & RUBBER INDUS" and "L.G. 8/7". There is also some text in the center of the stamp, but it is illegible. The stamp appears to be faded or of low quality.

・

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8.0 Performance Data:

The performance test data of the Nitrile examination glove manufactured by Sri. Anusham Rubber Industries Pvt Ltd is given below.

Measured Parameters of
Examination gloves (Nitrile)
manufactured by Anusham Rubber
	industries 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

CHARACTERISTICS	Before Ageing	After Ageing
Tensile Strength	18 - 20 mpa	16 - 18 mpa
Elongation at break %	750 - 800%	650-700%

INSPECTION LEVEL OF 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 shows a circular stamp with the text "SRI ANUSHAM RUBBER INDUSTRIES PVT. LTD." around the outer edge. Inside the circle, the word "NAGERCOIL" is printed vertically. A star symbol is also visible on the left side of the stamp.

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POWDER CONTENT : 120 +/- 20 mg per glove

PROTEIN CONTENT: 30 +/- 10 ppm

MOISTURE CONTENT: .0.8% max

BIOCOMPATABILITY: Biologically Compatible.

Clinical Data NA ・・

CONCLUSION OF PERFORMANCE TEST DATA: 10.

The Examination gloves (Nitrile) manufactured by Sri. Anusham Rubber Industries 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 effectivences will be provided on request.

Image /page/4/Picture/13 description: The image shows a circular stamp with text around the perimeter. The text reads "SRI ANUSHAM RUBBER" along the top arc and "NAGERCOIL" vertically in the center. There is a star symbol on the left side of the stamp.

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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 department's name around the perimeter. In the center of the logo is an abstract symbol that resembles a stylized caduceus or a human figure with outstretched arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nov 1 9 1999

Mr. N. Paramasivan Managing Director Managing Director
SRI Anusham Rubber Industries Private Limited SKI Panikandan Buildings Vandasery, Nagercoil-629001 Tamil Nadu, S. India

K993347 Re : Nitrile Examination Glove-Powdered Trade Name: Regulatory Class: I Product Code: LZA Dated: September 28, 1999 Received: October 5, 1999

Dear Mr. Paramasivan:

We have reviewed your Section 510(k) notification of intent to We have reviewed your Seccion 310(); isowe have determined the market the device referenced above und indications for device is substantially equivalence (resemarketed in interstate
use stated in the enclosure) to devices marketed in interest use stated in the enclosure) co de resement date of the Commerce prior to May 201 - on to devices that have been Medical Device Amendments, or to acvoor sions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, Food, Drug, and Cosmebic acc (inc.). Toda controls provisions
market the device, subject to the general controls of the Act The general controls provisions of the Act of the Act. of the Act. The general concril registration, listing of include requirements for amaractice, labeling, and devices, good manufacturing and adulteration.

If your device is classified (see above) into either class II
n the may and the collection TIT (Promorker Approval) it may (Special Controls) or class III (Premarket Approval), it may (Special Controls) of Crabb I controls. Existing major be subject to such addicionar concreason be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A rederal Regulations, free ar, ration assumes compliance with the Good Manufacturing Practice for Medical Devices:
the Good Manufacturing Practice for and that - through r General the Good Manufacturing Fracers 200 and that, through periodic (GMP) regulacion (2) Crk rare curr Administration (FDA) will GMP inspections, the rood and whe to comply with the GMP verify such assumpcions. Farraro or conoming your device in regulation may resure in regulated] weekning your device in

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Page 2 - Mr. Paramasivan

the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

Timo hy 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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3.0 INDICATIONS FOR USE:

APPLICANT SRI.ANUSHAM RUBBER INDUSTRIES PVT. LIMITED ・・ K993347 510(K) No. : NITRILE EXAMINATION GLOVES, POWDERED DEVICE NAME :

INDICATIONS FOR USE:

Nitrile Examination Glove is a disposable device made of Nitrile Latex intended for medi purpose, that is worn on the examiners hand or linger to prevent contamination between patie and Examiner. . - -

Image /page/7/Picture/4 description: The image shows a circular stamp with text around the perimeter. The text reads "SRI ANUSHAM RUBBER INDUSTR" along the top half of the circle. The bottom half of the circle reads "ADY S.P.O.". The center of the stamp contains the word "NAGERCOIL".

Clins S. Lin

(Division Sign-Off) Division of Dental, Infection Control, General Hospital De · · · · Number ·

PAGE N

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.