NIL, NITRILE EXAMINATION GLOVE - POWDERED

K993347 · Sri Anusham Rubber Industries Pvt., Ltd. · LZA · Nov 19, 1999 · General Hospital

Device Facts

• Record ID: K993347
• Device Name: NIL, NITRILE EXAMINATION GLOVE - POWDERED
• Applicant: Sri Anusham Rubber Industries Pvt., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Nov 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

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.

Device Story

Disposable nitrile latex examination glove; worn on examiner's hand or finger; serves as a physical barrier to prevent contamination between patient and examiner. Used in clinical settings by healthcare providers. Provides protection during patient examinations.

Clinical Evidence

Bench testing only. Data provided includes physical dimensions, tensile strength (18-20 MPa before ageing), elongation at break (750-800% before ageing), freedom from holes (AQL 1.5), powder content, protein content, and moisture content. Device meets or exceeds ASTM D3578 requirements.

Technological Characteristics

Disposable nitrile latex examination glove. Dimensions: 235-240 mm length; 70-107 mm width; 0.10 mm thickness. Physical properties: 18-20 MPa tensile strength (before ageing), 750-800% elongation (before ageing). Powder content: 120 +/- 20 mg/glove. Protein content: 30 +/- 10 ppm. Moisture content: 0.8% max. Biocompatible. Meets ASTM D3578-95 standards.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent cross-contamination between patient and examiner.

Regulatory Classification

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.

Predicate Devices

• Class I Patient Examination Gloves (Nitrile) 80LZA (meets ASTM D3578-95)

Submission Summary (Full Text)

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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 INDUSTRIES<br>PVT.LTD. |
|----------------------|--------------------------------------------------------------------------------|
| ADDRESS | PIONEER MANIKANDAN BUILDINGS<br>VADASERY,NAGERCOIL,<br>TAMILNADU,INDIA-629001. |
| PH.NO. | : 91-4652-33091, |
| FAX NO | : 91-4652-32871. |
| CONTACT PERSON | : MR. N. PARAMASIVAN<br>MANAGING DIRECTOR. |
| 3. DEVICE TRADE NAME | : NIL |
| COMMON NAME | : Patient Examination Glove (Nitrile) |

993347

- 4. 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.

- 6. 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 of<br>Examination gloves (Nitrile) manufactured<br>by Anusham Latex, | | | ASTM D3578<br>Requirement for<br>Examination glove<br>(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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|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
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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 from<br>Holes | Holes | S4 | 1.5 |
| Dimension | Width , Length<br>Thickness. | S2 | 4 |
| Physical<br>Property | Tensile<br>Strength,<br>Elongation at<br>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.

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8

POWDER CONTENT : 120 +/- 20 mg per glove

PROTEIN CONTENT: 30 +/- 10 ppm

MOISTURE CONTENT: .0.8% max

BIOCOMPATABILITY: Biologically Compatible.

9. 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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 ·

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