LATEX EXAMINATION GLOVES POWDER FREE

K982579 · Shiva Medicare , Ltd. · LYY · Aug 11, 1998 · General Hospital

Device Facts

• Record ID: K982579
• Device Name: LATEX EXAMINATION GLOVES POWDER FREE
• Applicant: Shiva Medicare , Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Aug 11, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Latex Examination Gloves Powder free is a powder free disposable device intended i for medical purpose, that is worn on the examiners hand or finger to prevent contamination between patient and Examiner.

Device Story

Latex examination glove (powder-free) worn on examiner's hand or finger; acts as physical barrier to prevent cross-contamination between patient and examiner. Used in clinical settings by healthcare professionals. Device provides protection during patient examinations. Benefits include reduced risk of contamination transmission.

Clinical Evidence

Bench testing only. Device performance evaluated against ASTM D3578-95 standards for length, width, thickness, tensile strength, elongation at break, and freedom from holes (AQL 1.5). Biocompatibility confirmed.

Technological Characteristics

Latex material; powder-free; dimensions and physical properties compliant with ASTM D3578-95. Tensile strength 20-22 MPa (before ageing); elongation at break 750-850% (before ageing). Biocompatible.

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 Latex (Powder free) 80LYY (meets ASTM D3578-95)

Submission Summary (Full Text)

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AUG | | 1998

K982579

Image /page/0/Picture/2 description: The image shows a logo with a stylized letter 'S' inside a triangle. The word 'SHIVA' is printed in bold, sans-serif font directly below the triangle. The logo is black and white.

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

| NAME<br>ADDRESS | M/s. SHIVA MEDICARE LIMITED<br>A 15, 16, 17(PART)<br>MADRAS EXPORT PROCESSINGZONE<br>KADAPERI, TAMBARAM,<br>CHENNAI 600 045.<br>INDIA. |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| PH.NO. | : 91-44-2368011/ 2368322/2362656/2362657. |
| FAX NO | : 91-44-2368327 |
| EMAIL | : [e-mail] |
| CONTACT PERSON | : MR. SATISH JAIN<br>EXECUTIVE DIRECTOR. |
| 3. DEVICE TRADE NAME<br>COMMON NAME | : NIL<br>: Patient Examination Glove (Powder free) |

Legally marketed device to which the company claiming equivalence: 4. Class I Patient Examination Gloves Latex ( Powder free) 80LYY that meets all the requirements of ASTM D3578 - 95.

5. DESCRIPTION OF THE DEVICE :

Class I Patient Examination Gloves Latex ( Powder free) 80LYY that meets all 'the requirements of ASTM D3578- 95.

6. Intended use of the Device:

Latex examination glove (Powder free) is a Powder free device intended for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner.

Image /page/0/Picture/11 description: The image shows the logo for Shiva Medicare Limited. The text "Shiva Medicare Limited" is written in a large, bold font. Below the company name, it says "100% Export Oriented Unit" in a smaller font. There is also a medical cross symbol on the left side of the image.

tered Office & Works : A 15-17. M.E.P.Z., Kadaperi, Tambaram, Chennai - 600 045 (INDIA) : 044/2368011/2368322 EMAIL: Shivan @md2.vsnl-net.in Telefax : 091-44-2368327. Grams : "SHVMEDI" orate Office : 808, Pragati Tower, 26, Rajendra Place, New Delhi - 110 008 (INDIA) nes : 011/5762314/5767046, Telex : 031-65886 SHIVA IN Fax [phone]

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# 7.0 TECHNOLOGICAL CHARACTERSTICS OF THE DEVICE COMAPARED TO PREDICATE DEVICE.

| Measured Parameters of Latex | | ASTM D3578 | |
|--------------------------------------|------|------------------------------------------|-----------------|
| Examination gloves (Powder free) | | Requirement for | |
| manufactured by Shiva Medicare Ltd., | | Latex Examination<br>glove (Powder free) | |
| 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 | SML VALUE * | ASTD 3578 REQUIREMENT | SML VALUE | ASTD 3578 Requirement |
| Tensile Strength | 20 - 22 mpa | 14 mpa min | 18 - 20 mpa | 14 mpa min |
| Elongation at break % | 750 - 850% | 700% min | 700-800% | 500% min |

# SML - SHIVA MEDICARE LIMITED

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#### PERFORMANCE REQUIREMENT:

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

#### POWDER CONTENT

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|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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## PROTEIN CONTENT:

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|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|--|
| SML VALUE | 1917 | |
| 00<br>00<br>pom<br>00<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>condidate dell'Annual | t<br>alue not fixed. | |

#### MOISTURE CONTENT:

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|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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#### BIOCOMPATABILITY:

| SML GLOVE | FDA REQUIREMENT |
|-------------------------|-------------------------|
| Biologically Compatible | Biologically Compatible |

Image /page/2/Picture/10 description: The image shows a circular stamp with the text "SRIKA MEDICARE LTD." around the outer edge. Inside the circle, the text "Madras - 600 045." is printed. The stamp appears to be a low-resolution scan or photocopy, as the text and lines are somewhat blurred and pixelated.

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#### Performance Data: 8.0

The performance test data of the powder free examination glove manufactured by Shiva Medicare Limited is given below.

| 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 |

#### PHY SICAL PROPERTIES

| CHARACTERISTICS | Before Ageing | After Ageing |
|-----------------------|---------------|--------------|
| Tensile Strength | 20 - 22 mpa | 18 - 20 mpa |
| Elongation at break % | 750-850% | 700-800% |

#### 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/7 description: The image shows a circular stamp with the text "SRIVA MEDICARE LTD." around the outer edge. Inside the circle, the text "Madras-600 045" is visible. The stamp appears to be somewhat faded or of low resolution, giving it a worn or vintage look. The text is arranged in a way that follows the circular shape of the stamp.

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POWDER CONTENT : 1 +/- 1 mg per glove

PROTEIN CONTENT: 80 +/- 20 ppm

MOISTURE CONTENT: .0.8% max

BIOCOMPATABILITY: Biologically Compatible.

NA 9. Clinical Data "

## 7. CONCLUSION OF PERFORMANCE TEST DATA:

The Powder free examination gloves manufactured by Shiva Medicare Limited

- Meet or exceed the ASTM D3578 ﺳﮯ
- Meet FDA Pin hole Requirement. -
- Meet labelling claim as shown by the data in 6 -

#### 8. ANY OTHER INFORMATION:

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

Image /page/4/Picture/12 description: The image shows a circular stamp with the text "SHIVA MEDICARE LTD." around the outer edge. Inside the circle, the text "Madras - 600 045" is present. A star symbol is located at the bottom 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 consists of a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### AUG | | 1998

M/s. Shiva Medicare Ltd. C/O Mr. James F. Logan Medical Reports Exchange 314 N Huntet Street Baltimore, Maryland 21202

Re: K982579 Latex Examination Gloves Powder-Free Trade Name: Requlatory Class: I Product Code: LYY Dated: July 24, 1998 Received: July 24, 1998

Dear Mr. Logan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbrandinq and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in 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

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Page 2 - Mr. Logan

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 requlation (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,

S. Dutman for

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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3.0 INDICATIONS FOR USE:

SHIVA MEDICARE LIMITED APPLICANT : K982579 : 510(K) No. LATEX EXAMINTION GLOVES POWDER FREE DEVICE NAME :

INDICATIONS FOR USE:

Latex Examination Gloves Powder free is a powder free disposable device intended i for medical purpose, that is worn on the examiners hand or finger to prevent contamination between patient and Examiner.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Clin S. Lin

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

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use X

(Optional Format 1-2-9