ROYAL SHIELD NON-STERILE POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH A PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM

K991745 · Shield Gloves Manufacturer (M) Sdn Bhd · LYY · Jun 23, 1999 · General Hospital

Device Facts

• Record ID: K991745
• Device Name: ROYAL SHIELD NON-STERILE POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH A PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM
• Applicant: Shield Gloves Manufacturer (M) Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Jun 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended 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 Green Latex Examination Gloves are non-sterile, disposable patient examination gloves. Designed for use by healthcare personnel in clinical settings to provide a protective barrier against contamination. Manufactured from latex, the gloves are powder-free to reduce potential irritation and meet ASTM D3578-95 standards for physical properties, including tensile strength and elongation. The device features a protein content labeling claim of 50 micrograms or less per gram. The gloves are worn on the hands of the clinician during patient examinations or procedures. The primary benefit is the reduction of cross-contamination risk between the healthcare provider and the patient.

Clinical Evidence

Bench testing only. Testing included physical dimension verification, tensile strength and ultimate elongation (before and after aging), water leak testing (1,000 ml test, 4.0% AQL), residual powder content (ASTM D6124-97), and residual protein levels (ASTM D5712-95). Biocompatibility testing confirmed the material is not a primary irritant and not a sensitizer.

Technological Characteristics

Latex patient examination glove; powder-free. Dimensions and physical properties conform to ASTM D3578-95. Residual powder content tested per ASTM D6124-97; residual protein content tested per ASTM D5712-95. Biocompatibility verified via dermal irritation and sensitization studies. Non-sterile.

Indications for Use

Indicated for use by healthcare and similar personnel as a protective barrier to prevent cross-contamination between the wearer and the patient.

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.

Submission Summary (Full Text)

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### APPENDIX H

# 510(k) SUMMARY SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR ROYAL SHIELD POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH A PROTEIN CONTENT LABELING

### Contact person : Ong Lay Mau

Gloves for Medical Application.

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 GREEN LATEX EXAM GLOVES Common Name - Exam gloves Classification Name - Patient examination glove (per 21 CFR 880.6250) Classification Information - Class I latex patient examination glove 80L YY, powder free and meeting all the requirements of ASTM-D3578-95 Standard Specification for Latex Examination

#### Device Description:

Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-95 Standard Specification for Latex 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>95 mm +/- 10mm<br>111mm +/- 10mm | 70 - 75 mm<br>80 - 85 mm<br>90 - 97 mm<br>105 - 111 mm |
| Length | 230 mm minimum<br>for all sizes | 242mm |
| Thickness -<br>Finger<br>Palm | 0.08mm min<br>0.08mm min | 0.08 mm min<br>0.08 mm min |

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K9911745

| | TENSILE STRENGTH | | ULTIMATE ELONGATION | |
|-----------------------------|------------------|----------|---------------------|----------|
| | ASTM-D3578-95 | SHIELD's | ASTM-D3578-95 | SHIELD's |
| Before Aging | 14.0 Mpa min | 21.0 Mpa | 700 % | 800% |
| After Aging<br>22 hrs @100C | 14.0 Mpa min | 16.0 Mpa | 500% | 750% |

2. Physical Properties (ASTM-D3578-95 Standard Specification for Latex Exam Gloves)

# 3. Water Tight Test

Using the FDA specified 1,000 ml water leak test, 80 pieces of each size of the gloves were tested and our results are as given below:

| BATCH # | SIZE | SAMPLE SIZE | LEAK STATUS | NUMBER<br>LEAKED |
|------------|---------|-------------|-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 9903031019 | X-Small | 200 | Yes | |
| 9903222024 | Small | 200 | Yes | 2 |
| 9904011027 | Medium | 200 | Yes | |
| 9903162023 | Large | 200 | Yes | ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ |

The above figures are within the FDA/ ASTM requirements for latex exam gloves of 4.0% AQL.

### 4. Biocompatibility

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

BIOCOMPATIBILITY TESTS

Primary Dermal Irritation Test

RESULTS

Not a primary irritant

Skin Sensitization Study

Not a sensitiser

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| TESTS | FDA INTERNAL<br>REQUIREMENT | SHIELD's |
|--------------------------------------------------|-----------------------------|-----------------------------------------------|
| Residual Powder<br>Content per<br>ASTM D 6124-97 | 2 mg/glove max | Range: 1.5-1.9mg/glove<br>Mean : 1.7 mg/glove |
| Presence of Cornstarch | Negative | Negative |

# 5. Total Residual Powder Content & Presence of Cornstarch

# 6. Residual Protein Level

| TESTS | FDA ALLOWABLE LEVEL | CLAIMED LEVEL |
|----------------|---------------------|---------------------------------------|
| ASTM D 5712-95 | < 50 μg/g | < 50 µg/g<br>Range: 27-33<br>Mean: 30 |

#### Conclusion :-

The data presented indicate that the Royal Shield Powder Free Green latex examination glove with a protein labeling claim qualifies to be labeled as such since it

- 1. meets/exceeds ASTM- D3578-95 Standard Specifications For Latex Examination Glove,
- 2. meets FDA pinhole requirements,
- 3. meets SHIELD's labeling claim of its being a powder free glove.
- 4. meets the protein labeling claim level at <50 µg/g

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with a human profile incorporated into its body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 23 1999

Shield Gloves Manufacturer (M) Sdn. Bhd. c/o Mr. E.J. Smith Smith Associates P.O. Box 4341 Crofton, Maryland 21114

Re : K991745

> Royal Shield™ Non-Sterile Powder-Free, Trade Name: Green Latex Examination Glove with Protein Content Labeling Claim (50 micrograms or less) Regulatory Class: I Product Code: LYY Dated: May 10, 1999 May 21, 1999 Received:

Dear Mr. Smith:

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 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. ਸ 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.

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Page 2 - Mr. Smith

this response to your premarket notification Please note: 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 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,

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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K991745

# INDICATIONS FOR USE STATEMENT

Applicant: Shield Gloves Manufacturer (M) Sdn Bhd.

510K Number:

Green Device Name: Royal Shield Powder Free Latex Examination Gloves With Content labeling Claim (50 micrograms or less 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)

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

OR

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

Chiu S. Lim

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