ROYAL SHIELD NON-STERILE BLUE COLORED POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MCGM OR

K992419 · Shield Gloves Manufacturer (M) Sdn Bhd · LYY · Sep 13, 1999 · General Hospital

Device Facts

• Record ID: K992419
• Device Name: ROYAL SHIELD NON-STERILE BLUE COLORED POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MCGM OR
• 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 the patient.

Device Story

Royal Shield powdered latex examination gloves; ambidextrous; blue colored; optional bubblegum scenting. Device functions as a physical barrier worn on hands by healthcare personnel to prevent contamination between clinician and patient. Manufactured to meet ASTM-D3578-99 standards for physical properties, including tensile strength and elongation. Includes protein labeling claim of <200 µg/g total water-extractable protein. Used in clinical settings; non-sterile.

Clinical Evidence

Bench testing only. Testing included physical property evaluation (tensile strength, elongation), water-tightness (pinhole) testing per ASTM D-3578-99, and biocompatibility (primary dermal irritation and skin sensitization). Residual protein levels were measured per ASTM D 5712-95, confirming levels <200 µg/g.

Technological Characteristics

Latex examination glove; powdered; blue color; optional bubblegum scent. Meets ASTM-D3578-99 specifications. Dimensions: 230 mm length; 0.08 mm min thickness (palm/finger). Tensile strength and elongation meet ASTM standards. Biocompatible (non-irritant, non-sensitizer). Protein content <200 µg/g.

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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# X G9 JY

## APPENDIX F

### 510(k) SUMMARY

# SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR ROYAL SHIELD BLUE COLORED POWDERED LATEX EXAMINATION GLOVES WITH AND WITHOUT BUBBLEGUM SCENTING & A PROTEIN LABELLING CLAIM

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

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| DATE<br>TESTED | TENSILE STRENGTH | | | | ULTIMATE ELONGATION | | | |
|----------------|------------------|--------|--------|--------|---------------------|------|--------|------|
| | AGED | UNAGED | AGED | UNAGED | | | | |
| | SHIELD | ASTM | SHIELD | ASTM | SHIELD | ASTM | SHIELD | ASTM |
| 20 May 99 | 27.7 | 14.0 | 24.3 | 14.0 | 950 | 500 | 900 | 700 |
| 20 May 99 | 25.2 | 14.0 | 30.3 | 14.0 | 900 | 500 | 900 | 700 |
| 20 May 99 | 29.1 | 14.0 | 30.1 | 14.0 | 950 | 500 | 900 | 700 |

## 2. Physical Properties (ASTM-D3578-99 Standard Specification for Latex Exam Gloves)

# 3. Water Tight Test Results*

| BATCH # | DATE<br>TESTED | SAMPLE SIZE | LEAK STATUS | NUMBER<br>LEAKED |
|-------------|----------------|-------------|-------------|------------------|
| 9028-9035 S | 15 May 99 | 315 | Yes | 4 |
| 9030-9036 M | 19 May 99 | 315 | Yes | 7 |
| 9027-9031 L | 19 May 99 | 200 | Yes | 3 |

* # APO3151/52

The above figures are within the ASTM D-3578-99 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

Primary Dermal Irritation Test

Skin Sensitization Study

RESULTS

Not a primary irritant

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- D3578-99 Standard Specifications For Latex Examination Glove,
- 2. meets FDA pinhole requirements,
- 3. meets the protein labeling claim level at <200 µg/g.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle's head and three stripes.

Public Health Service

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

K992419 Re : Royal Shield Non-Sterile Blue Powdered Latex Trade Name: Examination Gloves with Protein Content Labeling Claim (200 Micrograms or Less of Total Water Extractable Protein per gram) with or without Bubble Gum Scent Requlatory Class: I Product Code: LYY July 16, 1999 Dated: 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, 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 registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 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 one regulation entitled, "Misbranding by reference to
the regulation entitled, "Misbranding (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

y A. Ulatowsk Timoth 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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## INDICATIONS FOR USE STATEMENT

Applicant: Shield Gloves Manufacturer (M) Sdn Bhd

510K Number: K992419

Device Name: Royal Shield Powdered Latex Examination Gloves Dolor Will our Willi Rusbile Gurn SunT, Ontains 200 mcqm or less of Total Wefer of hockable
Indications For Use 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) | |
|---------------------------------------------------------------------|---------|
| <img alt="Signature" src="signature.png"/> | |
| (Division Sign-off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K992419 |

Prescription Use ......................... OR Over-The-Counter........................ 

Per 21 CFR 801.109