Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a simple examination glove and the description focuses on material properties and performance metrics related to physical characteristics, not data analysis or algorithmic processing. There are no mentions of AI, ML, image processing, or data sets for training/testing.

Therapeutic

No.
The device is a glove intended to prevent contamination, not to provide therapy.

Diagnostic

No
Explanation: The device is a nitrile examination glove, which is used to prevent contamination. Its function is not to diagnose medical conditions but rather to serve as a barrier between the examiner and the patient.

SaMD (Software as a Medical Device)

No

The device is a physical product (nitrile examination gloves) and the description focuses on material properties and physical performance tests, not software functionality.

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 clearly stated as a "disposable device... worn on the examiners hand or finger to prevent contamination between patient and Examiner." This describes a barrier device used for infection control during physical examination, not a device used to examine specimens from the human body in vitro (outside the body).
Device Description: It's described as "Class I Patient Examination Gloves (Nitrile)". This classification and description align with personal protective equipment used in healthcare settings, not IVDs.
Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or diagnostic purposes. The performance studies focus on physical properties of the glove (length, width, thickness, tensile strength, etc.) and freedom from holes, which are relevant to its function as a barrier, not its ability to diagnose a condition.

IVDs are devices used to examine specimens from the human body to provide information for diagnostic, monitoring, or screening purposes. This glove does not perform any such function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

LZA

Device Description

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

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)

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

Length, EX-S, 235-240 mm
, S, 235-240 mm
, M, 235-240 mm
, L, 235-240 mm
Width, EX S, 70MM
, S, 82 mm
, M, 93 mm
, L, 107 mm
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 from Holes, Holes, S4, 1.5
Dimension, Width , Length Thickness., S2, 4
Physical Property, Tensile Strength, Elongation at Break., S2, 4

POWDER CONTENT : 120 +/- 20 mg per glove
PROTEIN CONTENT: 30 +/- 10 ppm
MOISTURE CONTENT: .0.8% max
BIOCOMPATABILITY: Biologically Compatible.

CONCLUSION OF PERFORMANCE TEST DATA:
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 .

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.

Not Found

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

§ 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

11/19/99

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

.

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

| NAME | M/s. SRLANUSHAM RUBBER INDUSTRIES
PVT.LTD. |
|----------------------|--------------------------------------------------------------------------------|
| ADDRESS | PIONEER MANIKANDAN BUILDINGS
VADASERY,NAGERCOIL,
TAMILNADU,INDIA-629001. |
| PH.NO. | : 91-4652-33091, |
| FAX NO | : 91-4652-32871. |
| CONTACT PERSON | : MR. N. PARAMASIVAN
MANAGING 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.

81

1

7.0 TECHNOLOGICAL CHARACTERSTICS OF THE DEVICE COMAPARED TO PREDICATE DEVICE.

| Measured Parameters of
Examination gloves (Nitrile) manufactured
by Anusham Latex, | | | ASTM D3578
Requirement for
Examination 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.

2

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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LAND CONSULER OF
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CHARTER CARDER COLORICAL COLLECTION CO., IT
Market of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the |

PROTEIN CONTENT:

| Advertising the contribution

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|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
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                                                                                                                                                                | MALE CHANGE FOR A                                                                                                                                                                                                                                               |  |

MOISTURE CONTENT:

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And Antiques of the company of the control of the contribution of the contribution of the contribution of the contribution of the contribution of the contribution of the cont
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BIOCOMPATABILITY:

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NAMERA AN AND I AL L E L E S E S
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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.

・

3

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 from
Holes	Holes	S4	1.5
Dimension	Width , Length
Thickness.	S2	4
Physical
Property	Tensile
Strength,
Elongation at
Break.	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.

84

4

8

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.

5

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

6

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

2

Enclosure

7

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 ·

13

PAGE N

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

Device Description

Mentions image processing

Mentions AI, DNN, or ML

Input Imaging Modality

Anatomical Site

Indicated Patient Age Range

Intended User / Care Setting

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

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

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

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

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.

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.

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).

§ 880.6250 Non-powdered patient examination glove.

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

5. DESCRIPTION OF THE DEVICE :

7.0 TECHNOLOGICAL CHARACTERSTICS OF THE DEVICE COMAPARED TO PREDICATE DEVICE.

PHYSICAL PROPERTIES

PERFORMANCE REQUIREMENT:

POWDER CONTENT

PROTEIN CONTENT:

THE AND AND AND AND AND FOR FOR AND C A FREE L CANNUAL COLL COLLECT LEASE LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST | 400-400-4000 0-400-4-40-4-4-4-4-4-4-4-4-4-4-4-4-4-4-

MOISTURE CONTENT:

BIOCOMPATABILITY:

And Comments of Children Comments of Children Comments of Children Comments of the world by the world in the may be and . | -----------

8.0 Performance Data:

PHYSICAL PROPERTIES

INSPECTION LEVEL OF AQL:

CONCLUSION OF PERFORMANCE TEST DATA: 10.

11. ANY OTHER INFORMATION:

INDICATIONS FOR USE:

THE AND AND AND AND AND FOR FOR AND
C
A FREE L CANNUAL COLL COLLECT LEASE LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST | 400-400-4000 0-400-4-40-4-4-4-4-4-4-4-4-4-4-4-4-4-4-

And Comments of Children Comments of Children Comments of Children
Comments of the world by the world in the may be and
. | -----------