NON-STERILE POWDER FREE MULTICOLOR - RED, BLUE, PURPLE AND YELLOW LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING

K052016 · Sgmp Co., Ltd. · LYY · Sep 1, 2005 · General Hospital

Device Facts

• Record ID: K052016
• Device Name: NON-STERILE POWDER FREE MULTICOLOR - RED, BLUE, PURPLE AND YELLOW LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING
• Applicant: Sgmp Co., Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Sep 1, 2005
• 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

Non-sterile, powder-free, multicolored latex examination gloves. Designed for use by healthcare personnel to provide a barrier against contamination between the examiner and the patient. Manufactured from latex; meets ASTM D3578-01aE2 standards for physical dimensions, tensile strength, and elongation. Device is disposable; intended for single use. Provides a protein labeling claim of 50 micrograms or less per square decimeter. Used in clinical or similar settings to maintain hygiene and prevent cross-contamination.

Clinical Evidence

Bench testing only. Testing included physical property evaluation (tensile strength, elongation), water-tightness (1,000 ml leak test), residual powder content (ASTM D6124-00), and residual protein levels. Results confirmed compliance with ASTM D3578-01aE2 standards and FDA requirements for powder-free latex examination gloves.

Technological Characteristics

Latex material; powder-free; multicolored. Dimensions and physical properties (tensile strength, elongation) conform to ASTM D3578-01aE2. Residual powder content < 2 mg/glove; residual protein level < 50 µg/dm2. Non-sterile.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent contamination between patient and examiner. Suitable for healthcare and similar personnel.

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

• POWDER FREE BLUE LATEX EXAM GLOVES (K011377)
• POWDER-FREE PINK LATEX EXAM GLOVES (K011371)

Submission Summary (Full Text)

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APPENDIX L

### 510(k) SUMMARY SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR POWDER-FREE MULTICOLOR LATEX EXAMINATION GLOVES

Submitted For : SGMP Company Limited, 181 Moo 6, Tambol Kanpaengpetch, Rattaphum, Songkhla 90180, Thailand.

- Submitted By: Tucker & Associates Official Correspondent for SGMP Co Ltd Janna P. Tucker, President - CEO 198 Avenue de la D'emcrald, Sparks, NV 89434-9550 Phone No : 775-342-2612 Fax No : 775-342-2613 E-mail: [e-mail]
Equivalent Predicate Device: POWDER FREE BLUE LATEX EXAM GLOVES which was granted a 510(k) # K011377 and POWDER-FREE PINK LATEX EXAM GLOVES which was also granted a 510 (k) # K011371 as shown in APPENDIX M

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

### Device Information:

Trade Name - NON-STERILF POWDER FREE MULTICOLOR 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, powder free and meeting all the requirements of ASTM-D3578-01aE2 Standard Specification for U.atex Examination Gloves for Medical Application.

### Device Description:

Class I latex patient examination gloves 80LYY, powder free and mecting all the requirements of ASTM-D3578-01aE2 Standard Specification for Latex Examination Glowes 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.

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Technological Characteristics of Device:

## 1. Dimension

| DIMENSION | ASTM D3578-01aE2 | SGMP |
|--------------------|---------------------------------|--------------|
| X-Small | 70 mm +/- 10 mm | 70 – 80 mm |
| Small | 80 mm +/- 10 mm | 80 – 85 mm |
| Medium | 95 mm +/- 10 mm | 90 – 97 mm |
| Large | 111 mm +/- 10 mm | 105 - 111 mm |
| Length | 230 mm minimum<br>for all sizes | 242 mm |
| Thickness - Finger | 0.08 mm min | 0.13 mm min |
| Palm | 0.08 mm min | 0.1 mm min |

## 2. Physical Properties (ASTM-D3578-00aE2 Standard Specification for Latex Exam Gloves) on Lot# 4144

| | TENSILE STRENGTH | | ULTIMATE ELONGATION | |
|--------------|------------------|------|---------------------|------|
| | ASTM-D3578-00aE2 | SGMP | ASTM-D378-00aE2 | SGMP |
| | Mpa | Mpa | % | % |
| Before Aging | 18.0 | | 650 | |
| X-Small | | 23.5 | | 890 |
| Small | | 26.8 | | 800 |
| Medium | | 22.5 | | 850 |
| Large | | 29.2 | | 870 |
| After Aging | 14.0 | | 500 | |
| X-Small | | 22.8 | | 780 |
| Small | | 27.5 | | 820 |
| Medium | | 28.3 | | 750 |
| Large | | 26.8 | | 820 |
| | | | | |

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### 3. Water Tight Test

| BATCH # | SIZE | SAMPLE SIZE | LEAK STATUS | NUMBER<br>LEAKED |
|-----------------|---------|-------------|-------------|------------------|
| UN-AGED<br>4144 | X-Small | 125 | No | 0 |
| 4144 | Small | 125 | Yes | 1 |
| 4144 | Medium | 125 | Yes | 2 |
| 4144 | Large | 125 | No | 0 |
| AGED<br>4144 | X-Small | 125 | No | 0 |
| 4144 | Small | 125 | Yes | 1 |
| 4144 | Medium | 125 | Yes | 1 |
| 4144 | Large | 125 | Yes | 2 |

Using the FDA specified 1,000 ml water leak test, 125 pieccs of each size of the gloves were tested and our results are as given below.

The above figures are within the ASTM D3578-00aE2 requirements for latex exam gloves of 2.5% AQL.

#### Biocompatibility 4.

The bio-compatibility test results are as per attached in APPENDIX K and show that the gloves passed the tests for examination gloves.

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

| TEST | FDA<br>REQUIREMENT | INTERNAL SGMP's |
|---------------------------------------------|--------------------|--------------------------------------------------|
| Residual Powder Content<br>(ASTM D 6124-00) | 2 mg/glove max | Ranger: 0.4 - 1.0 mg/glove<br>Mean: 0.8 mg/glove |
| Presence of Cornstarch | Negative | Negative |

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## 6. Residual Protein Level.

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### Conclusion:-

The data presented indicate that the Non-sterile Powder Free Multicolor Latex Examination Gloves.

- 1. meets/exceeds ASTM- D3578-00aE2 Standard Specifications For Latex Examination Glove,
- 2. meets FDA pinhole requirements,
- 3. meets FDA claim criterion of a powder free glove.
- 4. meets the protein labelling claims level at <50 µg/ dm2

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal features an abstract eagle design with three stylized lines representing the eagle's body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle emblem.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 0 1 2005

SGMP Company Limited C/O Janna P. Tucker Tucker & Associates 198 Avenue De La D'Emerald Sparks, Nevada 89434

Re: K052016

Trade/Device Name: Non-Sterile, Latex, Powder-Free Patient Examination Glove (Multicolored), with Protein Labeling Claim (50 Micrograms or Less) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: August 9, 2005 Received: August 25, 2005

Dear Ms. Tucker:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting ( vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Tucker

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements moan that I Drima muse statutes and regulations administered by other Federal agencies. or the Fer of all the Act's requirements, including, but not limited to: registration r od intilety (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice und listing (21 er read vo the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mo reter notification. The FDA finding of substantial equivalence of your device to a premaired 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), 11 you desire specific at Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the maj overs Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Syndie Y. Michie Dmd.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Applicant: SGMP Company Ltd.

510(k) Number (if known): K052016

Device Name: _Non-Sterile, Latex, Powder-Free Patient Examination Gloves (Multicolored), with Protein Labeling Claim (50 Micrograms or less)

Indications For Use:

The Non-Sterile, Latex, Powder-Free Patient Examination Gloves (Multicolored), with Protein Labeling Claim (50 Micrograms or less) 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.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sheila f. Murphy, M.D. 8/31/15
(Division Sign-Off)

Division of Anesthesiology. General Hospital Infection Control, Dental Devices

510(k) Number: K052016

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