NON-STERILE, LATEX POWDER FREE PATIENT EXAMINATION GLOVES (MULTICOLORED WITH XYLITOL AND CALCIUM CARBONATE)

K071060 · Sgmp Co., Ltd. · LYY · Jul 26, 2007 · General Hospital

Device Facts

• Record ID: K071060
• Device Name: NON-STERILE, LATEX POWDER FREE PATIENT EXAMINATION GLOVES (MULTICOLORED WITH XYLITOL AND CALCIUM CARBONATE)
• Applicant: Sgmp Co., Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Jul 26, 2007
• 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 latex examination gloves; multicolored; treated with xylitol and calcium carbonate. Worn by healthcare personnel on hands/fingers during patient examinations. Acts as a physical barrier to prevent cross-contamination between examiner and patient. Disposable design. Bench testing confirms compliance with ASTM D3578-01aE2 standards for dimensions, tensile strength, elongation, and water-tightness (pinhole resistance). Residual protein levels maintained at <50 µg/dm².

Clinical Evidence

Bench testing only. Testing included physical property evaluation (tensile strength, ultimate elongation), water leak testing (1,000 ml water leak test per ASTM D3578-00aE2), residual powder content (ASTM D6124-00), and residual protein levels (ASTM D5712-99). Results confirmed compliance with FDA requirements and ASTM standards. No clinical data provided.

Technological Characteristics

Material: Latex. Additives: Xylitol and Calcium Carbonate. Form factor: Multicolored, powder-free, non-sterile examination glove. Dimensions: 241 mm length; palm thickness 0.10 mm min; finger thickness 0.13 mm min. Standards: ASTM D3578-01aE2, ASTM D6124-00, ASTM D5712-99. Protein content: <50 µg/dm².

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. Intended for healthcare personnel and similar users.

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 (MULTICOLORED) LATEX EXAM GLOVES (K052016)

Submission Summary (Full Text)

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K07/060

JUL 26 2007

APPENDIX L

### 510(k) SUMMARY

### SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR POWDER-FREE LATEX EXAMINATION GLOVES (MULTICOLORED WITH XYLITOL AND CALCIUM CARBONATE)

Submitted For : SGMP Courpany Limited, 181 Moo 6, Tambol Kampaenspetch, Rattaphum, Songkhla 90180, Thailand.

Submitted By: Tucker & Associates Official Correspondent for SGMP Co Ltd Janna P. Tucker, President - CEO 198 Avenue de la D'emerald, Sparks, NV 89434-9550 Phone No : 775-342-2612 Fax No : 775-342-2613 E-mail: [e-mail]

Equivalent Predicate Device: POWDER FREE (MULTICOLORED) LATEX EXAM GLOVES which was granted a 510(k) # K052016

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

### Device Information:

Trade Name -- NON-STERILE POWDER FREE LATEX EXAMINATION GLOVES (MULTICOLORED WITH XYLITOL AND CALCIUM CARBONATE)

### 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 Latex Examination Gloves for Medical Application

### Device Description:

Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-01aE2 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.

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: 上一篇:

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 | 241 mm |
| Thickness - Finger | 0.08 mm min | 0.13 mm min |
| Palm | 0.08 mm min | 0.10 mm min |

## 2. Physical Properties (ASTM-D3578-00gE2 Standard Specification for Latex Exam Gloves) on Lot# 6171

| | TENSILE STRENGTH | | ULTIMATE ELONGATION | |
|-----------------------------------------------------|------------------|-------------------------------------|---------------------|-------------------------------|
| | ASTM-D3578-00aE2 | SGMP | ASTM-D3578-00aE2 | SGMP |
| Before Aging<br>X-Small<br>Small<br>Medium<br>Large | Mpa<br>18.0 | Mpa<br>26.5<br>23.7<br>27.0<br>28.5 | %<br>650 | %<br>875<br>805<br>830<br>840 |
| After Aging<br>X-Small<br>Small<br>Medium<br>Large | 14.0 | 23.0<br>24.5<br>25.8<br>25.5 | 500 | 750<br>800<br>730<br>830 |

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### 3. Water Tight Test

Using the FDA specified 1,000 ml water leak test, 125 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 |
|---------|---------|-------------|-------------|------------------|
| UN-AGED | | | | |
| 6171 | X-Small | 125 | Yes | 1 |
| 6171 | Small | 125 | Yes | 2 |
| 6171 | Medium | 125 | No | 0 |
| 6171 | Large | 125 | Yes | 1 |
| AGED | | | | |
| 6171 | X-Small | 125 | No | 0 |
| 6171 | Small | 125 | Yes | 1 |
| 6171 | Medium | 125 | Yes | 1 |
| 6171 | Large | 125 | Yes | 2 |

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

#### Biocompatibility ব

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 : 0.6 -1.4 mg/glove<br>Mean : 1.1 mg/glove |
| Presence of Cornstarch | Negative | Negative |

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## 6. Residual Protein Level.

| TEST | FDA ALLOW ABLE LEVEL | CLAIMED LEVEL |
|----------------|----------------------|------------------|
| ASTM D 5712-99 | < 50 $\mu$ g/dm² | < 50 $\mu$ g/dm² |

### Conclusion:-

The data presented indicate that the Non-sterile Powder Free Latex Examination Gloves, (Multicolored with Xylitol and Calcium Carbonate)

- 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 labeling claims level at <50 µg/ dm2

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 26 2007

SGMP Company Limited C/O Janna P. Tucker President-Chief Executive Officer Tucker and Associates 198 Avenue De La D' Emerald Sparks, Nevada 89434-9550

Re: K071060

Trade/Device Name: Non-Sterile, Latex Powder Free Patient Examination Gloves (Multicolored with Xylitol and Calcium Carbonate), with Protein Labeling Claims (50 Micrograms or Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: June 26, 2007 Received: June 29, 2007

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 your 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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in 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) 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), please contact the Office of 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Snite Y. Michie Omd.

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

#### SGMP COMPANY LTD. APPLICANT:

**510(k) NUMBER (if known):**

**510(k) NUMBER (if known):** K071060

DEVICE NAME:

Non-Sterile, Latex Powder Free Patient Examination Gloves (Multicolored with Xylitol and Calcium Carbonate), with Protein Labeling claims (50 Micrograms or less)

# Indications For Use:

This Non-Sterile, Latex Powder Free Patient Examination Gloves (Multicolored with Xylitol and Calcium Carbonate, with Protein Labeling claims (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 ..... Per 21 CFR 801.109 AND/OR

Over-The-Counter Use ... A........ (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)

J10(k) Number:

Shule R. Murphy ho
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Division Sign-Off)
Division of Anesthesiology, General Hospital
fection Control, Dental Devices