← Product Code [LZA](/productcode/LZA) · K972757

# ROYAL SHIELD NON-STERILE POWDERFREE, COLORED NITRILE EXAMINATION GLOVE (K972757)

_Shield Gloves Manufacturer (M) Sdn Bhd · LZA · Oct 29, 1997 · General Hospital · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K972757

## Device Facts

- **Applicant:** Shield Gloves Manufacturer (M) Sdn Bhd
- **Product Code:** [LZA](/productcode/LZA.md)
- **Decision Date:** Oct 29, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6250
- **Device Class:** Class 1
- **Review Panel:** General Hospital

## Indications for Use

A medical glove to be worn on the hand of the health care and similar personnel to prevent contamination between health care personnel and patient.

## Device Story

Royal Shield powder-free colored nitrile examination gloves; worn by healthcare personnel; barrier protection to prevent cross-contamination between clinician and patient; non-sterile; nitrile material; tested for water-tightness, tensile strength, and biocompatibility; meets ASTM draft standards for nitrile examination gloves.

## Clinical Evidence

Bench testing only. Includes water leak testing (1,000 ml test, 80 samples), tensile strength and ultimate elongation testing (before and after aging), residual powder content (ASTM draft method), and biocompatibility (primary dermal irritation and skin sensitization).

## Technological Characteristics

Nitrile rubber examination glove; powder-free; colored; non-sterile. Dimensions: 240mm minimum length; 0.08mm minimum finger/palm thickness. Meets ASTM D 3578-95 (except ultimate elongation) and ASTM Draft Standard for Nitrile Examination Gloves. Biocompatible per dermal irritation and sensitization testing. Residual powder < 2 mg/glove.

## Regulatory 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.

## Submission Summary (Full Text)

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# 972757

#### APPENDIX J

### OCT 29 1997

#### 510(K) SUMMARY SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR ROYAL SHIELD POWDER FREE NITRILE EXAMINATION GLOVES

#### Contact person : Ong Lay Mau

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

#### Device Information:

| Trade Name                 | - ROYAL SHIELD™ POWDER FREE COLORED NITRILE<br>EXAMINATION GLOVES  |
|----------------------------|--------------------------------------------------------------------|
|                            |                                                                    |
| Common Name                | - Exam gloves                                                      |
| Classification Name        | - Patient examination glove (per 21 CFR 880.6250)                  |
| Classification Information | - Class I, 80 LZA - Nitrile patient examination glove, Powder free |
|                            | Meets all requirements of the ASTM Draft Standard Specification    |
|                            | for Nitrile Examination Gloves for Medical Application.            |

#### Device Description:

Class I Nitrile patient examination gloves 80LZA, powder free and meeting all the requirements of the ASTM Draft Standard Specification for Nitrile Examination Gloves for Medical Application.

#### Intended Use of Device:

A medical glove to be worn on the hand of the health care and similar personnel to prevent contamination between health care personnel and patient.

#### Technological Characteristics of Device:

#### 1. Dimension

| DIMENSION                           | ASTM D3578-95                                                        | ROYAL SHIELD                                           |
|-------------------------------------|----------------------------------------------------------------------|--------------------------------------------------------|
| X-Small<br>Small<br>Medium<br>Large | 70 mm +/-10 mm<br>80 mm +/- 10mm<br>90 mm +/- 10mm<br>100mm +/- 10mm | 70 - 75 mm<br>80 - 85 mm<br>90 - 97 mm<br>105 - 100 mm |
| Length                              | 230 mm minimum<br>for all sizes                                      | 240mm min.<br>for all sizes                            |
| Thickness -<br>Finger<br>Palm       | 0.08mm minimum<br>0.08mm minimum                                     | 0.08 mm min.<br>0.08 mm min.                           |

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#### Physical Properties 2.

| TESTS                         | TENSILE STRENGTH  |                          |                           | ULTIMATE ELONGATION |                          |                           |
|-------------------------------|-------------------|--------------------------|---------------------------|---------------------|--------------------------|---------------------------|
|                               | ASTM<br>D 3578-95 | ASTM<br>DRAFT<br>NITRILE | SHIELD<br>GLOVES<br>MFR'S | ASTM<br>D 3578-95   | ASTM<br>DRAFT<br>NITRILE | SHIELD<br>GLOVES<br>MFR'S |
| BEFORE AGING                  | 14.0 MPa          | 12.5 MPa                 | 15.6 MPa                  | 700%                | 500%                     | 650%                      |
| AFTER AGING<br>22 HRS @ 100°C | 14.0 MPa          | 12.5 MPa                 | 14.5 MPa                  | 500%                | 400%                     | 575%                      |

Our Royal Shield™ Powder free, Colored Nitrile gloves meets all the current ASTM D 3578-95 standards except for Ultimate Elongation Percentages Before Aging.

However, these gloves meet all the specifications of the ASTM Draft Specification for "Nitrile Rubber Examination Gloves for Medical Application" (see APPENDIX B-1) and will conform to all the requirements of the final ASTM standard for Nitrile gloves when published.

#### 3. Water Tight Test

Using the FDA specified 1,000 ml water leak test, 80 pieces of the gloves were tested and our results are as given below: 【送料無料】【送料無料】【送料無料】【送料無料】【送料無料】【送料無料】【送料無料】【送料無料】【送料無料】【送料無料】【送料無料】【送料無料】【

| BATCH #    | SIZE   | SAMPLE SIZE | LEAK STATUS | NUMBER<br>LEAKED |
|------------|--------|-------------|-------------|------------------|
| 9705261002 | Small  | 80          | No          | 0                |
| 9705261002 | Medium | 80          | Yes         | 1                |
| 9705261002 | Large  | 80          | Yes         | 1                |

The above meets the FDA Water Leak Test Requirements.

#### 4. Biocompatibility

The test results below shows that the gloves meet FDA biocompatibility requirements:

| BIOCOMPATIBILITY TESTS         | RESULTS |
|--------------------------------|---------|
| Primary Dermal Irritation Test | Passes  |
| Skin Sensitization Study       | Passes  |

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K972757

| TESTS                                             | FDA INTERNAL<br>REQUIREMENTS    | SHIELD GLOVES MFR'S                                 |
|---------------------------------------------------|---------------------------------|-----------------------------------------------------|
| RESIDUAL POWDER<br>CONTENT<br>(ASTM DRAFT METHOD) | NOT EXCEEDING<br>2 MG PER GLOVE | RANGE: 1.6-2.0 MG/ GLOVE<br>MEAN : 1.8 MG PER GLOVE |
| CORNSTARCH PRESENCE<br>(IODINE TEST)              | NEGATIVE                        | NEGATIVE                                            |

#### 5. Total Residual Powder Content & Presence of Cornstarch

Our above glove conforms to FDA's Internal Requirement not to exceed 2 mg/glove of total powder residue (using ASTM Draft Method for Residual Powder on Medical Gloves) and negative Iodine test.

#### CONCLUSION :-

It is concluded that the Royal Shield TM Powder Free, Colored Nitrile gloves meet .-

- ASTM D 3578-95 with the exception of Ultimate Elongation Percentages Before Aging (700% standard Vs. 650% for our product).
- ASTM Draft Standard Specification for Nitrile Examination Gloves for Medical Application and will conform to this final standard when published.
- FDA Internal Requirement not to exceed 2 mg/glove of total powder residue (using ASTM Draft Method for Residual Powder on Medical Gloves.
- ASTM D 5151-90 Test Method for Detection of Holes in Medical Gloves
- the FDA Water Leak Test requirements

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES ----------------------------------------------------------------------------------------------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized wing or feather shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

OCT 2 9 1997

Mr. Onq Lay Mau Executive Director Shield Gloves Manufacturer (M) Sdn. Bhd. 87, 2nd. Floor, Jalan SS 15/4-C Subang Jaya Petaling Jaya, Selangor Darul Ehsan Malaysia

Re : K972757 ROYAL SHIELD™ Non-Sterile Powderfree, Trade Name: Colored Nitrile Examination Glove (Blue) Regulatory Class: I Product Code: LZA Dated: October 11, 1997 Received: October 20, 1997

Dear Mr. Mau:

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, Drug, 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 reqistration, 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 (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. ਉ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements

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Page 2 - Mr. Mau

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 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 leqally 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) 594-4618. 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" (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,

Alilatoun

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

Enclosure

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## INDICATIONS FOR USE STATEMENT

Applicant: Shield Gloves Manufacturer (M) Sdn Bhd

510K Number: |<972757

Device Name: ROYAL SHIELD ™ Powder Free Colored Nitrile Examination Gloves / BULC

Indications For Use :

This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient. . ... -....

Concurrence of CDRH Office of Device Evaluation (ODE)

・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

Clim S. Lin

(Division Sign-Off Division of Dental. and General Ha 510(k) Numbe

Prescription Use ...... Per 21 CFR 801.109

Over-The-Counter........X......

OR

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**Source:** [https://fda-staging.innolitics.com/device/K972757](https://fda-staging.innolitics.com/device/K972757)

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