ROYAL SHIELD NON-STERILE POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABELING CLAIM) 200 MCGM OR LESS OF TOTAL WATER EXTR

K992417 · Shield Gloves Manufacturer (M) Sdn Bhd · LYY · Sep 13, 1999 · General Hospital

Device Facts

• Record ID: K992417
• Device Name: ROYAL SHIELD NON-STERILE POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABELING CLAIM) 200 MCGM OR LESS OF TOTAL WATER EXTR
• Applicant: Shield Gloves Manufacturer (M) Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Sep 13, 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 Powdered Latex Examination Gloves are non-sterile, ambidextrous latex gloves designed for use by healthcare personnel. The device acts as a physical barrier to prevent cross-contamination between the wearer and the patient. The gloves are manufactured to meet ASTM-D3578-99 standards for physical properties, including tensile strength and ultimate elongation, and are tested for water-tightness (pinhole resistance) and biocompatibility (dermal irritation and sensitization). The device features a protein labeling claim of <200 µg/g of total water-extractable protein. The gloves are intended for use in clinical or similar settings where barrier protection is required.

Clinical Evidence

Bench testing only. Evidence includes physical property testing (tensile strength, elongation) per ASTM-D3578-99, water leak testing (1,000 ml) showing compliance with 2.5% AQL, and biocompatibility studies (primary dermal irritation and skin sensitization). Residual protein levels were verified per ASTM D 5712-95.

Technological Characteristics

Material: Latex. Standards: ASTM-D3578-99 (physical properties), ASTM D 5712-95 (protein levels). Form factor: Ambidextrous, various sizes (XS-XL), 230 mm length, 0.08 mm minimum thickness. Energy source: None (mechanical barrier). Connectivity: None. Sterilization: Non-sterile.

Indications for Use

Indicated for use by healthcare and similar personnel as a medical glove worn on the hand to prevent contamination between the personnel 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 POWDERED LATEX 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 POWDERED LATEX EXAMINATION GLOVES Common Name - Exam gloves Classification Name - Patient examination glove (per 21 CFR 880.6250) Classification Information - Class I latex patient examination glove 80LYY, powdered and meeting all the requirements of ASTM-D3578-99 Standard Specification for Latex Examination Gloves for Medical Application.

#### Device Description:

Class I latex patient examination gloves 80LYY, powdered and meeting all the requirements of ASTM-D3578-99 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.

#### 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 | | Ambidextrous | | Size Fitted |
|-------------------------------|----------------------------|-----------------|-----|---------------|
| Width | X-Small | 70 mm +/- 10 mm | 5.5 | 70 +/- 10 mm |
| | Small | 80 mm +/- 10mm | 6.0 | 76 +/- 10mm |
| | Medium | 95 mm +/- 10mm | 6.5 | 83 +/- 10mm |
| | Large | 111mm +/- 10mm | 7.0 | 89 +/- 10mm |
| | | | 7.5 | 95 +/- 10mm |
| | | | 8.0 | 102 +/- 10mm |
| | | | 8.5 | 108 +/- 10 mm |
| | | | 9.0 | 114 +/- 10mm |
| Length | | 230 mm | | |
| Thickness -<br>Finger<br>Palm | 0.08 mm min<br>0.08 mm min | | | |

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# 2. Physical Properties (ASTM-D3578-99 Standard Specification for Latex Exam Gloves) After Real Time Ageing On Gloves Produced in 1994.

| | TENSILE STRENGTH | | ULTIMATE ELONGATION | | | | | |
|----------------|------------------|--------------|---------------------|----------------|----------------|--------------|------------------|----------------|
| DATE<br>TESTED | AGED<br>SHIELD | AGED<br>ASTM | UNAGED<br>SHIELD | UNAGED<br>ASTM | AGED<br>SHIELD | AGED<br>ASTM | UNAGED<br>SHIELD | UNAGED<br>ASTM |
| 10.3.97 | 21.8 | 14.0 | 25.1 | 14.0 | 975 | 500 | 922 | 700 |
| 10.3.98 | 27.3 | 14.0 | 27.3 | 14.0 | 877 | 500 | 790 | 700 |
| 11.3.99 | 22.0 | 14.0 | 26.2 | 14.0 | 928 | 500 | 854 | 700 |

Batch # 9410243147 & 9411153155

## 3. Water Tight Test After Real Time Ageing

Using the FDA specified 1,000 ml water leak test, 80 pieces of the gloves produced in 1994 over a period of three years of storage were tested and our results are as given below:

| BATCH # | DATE<br>TESTED | SAMPLE SIZE | LEAK STATUS | NUMBER<br>LEAKED |
|--------------|----------------|-------------|-------------|------------------|
| 9410243147/ | Mar 10, 1997 | 125 | Yes | 2 |
| 9411153155 | Mar 10, 1998 | 125 | Yes | 1 |
| Size L/R 6.0 | Mar 11, 1999 | 125 | Yes | 2 |

The above figures are within the FDA/draft ASTM requirements for latex exam gloves of 2.5% AQL.

#### 4. Biocompatibility

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

| BIOCOMPATIBILITY TESTS | RESULTS |
|--------------------------------|------------------------|
| Primary Dermal Irritation Test | Not a primary irritant |
| Skin Sensitization Study | Not a sensitiser |

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## 5. Residual Protein Level

| TESTS | FDA ALLOWABLE LEVEL | CLAIMED LEVEL |
|----------------|---------------------|-------------------------------|
| ASTM D 5712-95 | - | < 200 µg/g<br>Range:<br>Mean: |

The data presented indicate that the Royal Shield Powdered latex examination glove

- 1. meets/exceeds ASTM- D3578-95 Standard Specifications For Latex Examination Glove,
- 2. meets FDA pinhole requirements,
- 3. meets SHIELD's shelf life labeling claim of four years,
- 4. meets the protein labeling claim level at <200 µg/g.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 3 1999

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

Re: K992417 Royal Shield Non-Sterile Powdered Latex Trade Name: Examination Gloves with Protein Labeling Claim (200 Micrograms or Less of Total Water Extractable Protein per gram) Regulatory Class: I Product Code: LYY Dated: July 16, 1999 Received: July 20, 1999

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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your

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Page 2 - Mr. Smith

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 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 Radioloqical Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

Applicant: Shield Gloves Manufacturer (M) Sdn Bhd.

K992417 510K Number:

Device Name: Royal Shield Powdered Latex Examination Gloves > Profer Donor ham on less of Total Water extreastable probes gram 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)

OR Over-The-Counter .. Prescription Use ... ... Per 21 CFR 801.109 (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number

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