NON-STERILE POWDER FREE GREEN LATEX PATIENT EXAM GLOVES WITH SURFACE COATING & PROTEIN LABELING CLAIM (<50UG/DM2)

K023537 · Sgmp Co., Ltd. · LYY · Nov 20, 2003 · General Hospital

Device Facts

• Record ID: K023537
• Device Name: NON-STERILE POWDER FREE GREEN LATEX PATIENT EXAM GLOVES WITH SURFACE COATING & PROTEIN LABELING CLAIM (<50UG/DM2)
• Applicant: Sgmp Co., Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Nov 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A 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.

Device Story

Non-sterile, powder-free green latex patient examination glove; coated with nopal, aloe vera, and vitamin E for donning aid. Designed for use by healthcare personnel in clinical settings to provide a protective barrier against contamination. Device functions as a physical barrier; no electronic or software components. Performance verified against ASTM D3578-01ae2 standards for dimensions, tensile strength, elongation, and water-tight integrity. Protein content labeled at <50 µg/g. Intended to reduce risk of cross-contamination during patient examinations.

Clinical Evidence

Bench testing only. Testing included physical dimensions, tensile strength, ultimate elongation (before and after aging), water-tight leak testing (1,000 ml leak test), residual powder content (ASTM D6124-01), and residual protein levels. All results met or exceeded ASTM D3578-01ae2 requirements and FDA criteria for powder-free gloves.

Technological Characteristics

Material: Latex. Coating: Nopal, Aloe Vera, Vitamin E. Dimensions: 242mm length; 0.08mm minimum thickness. Physical properties: Tensile strength >14.0 MPa; Elongation >700%. Standards: ASTM D3578-01ae2. Powder content: 0.5-0.8 mg/glove. Protein content: <50 µg/g. Non-sterile.

Indications for Use

Indicated for use by healthcare personnel as a disposable barrier worn on the hand or finger to prevent cross-contamination between patient and examiner.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 4 2003

SGMP Company Limited C/O Ms. Janna P. Tucker Official Correspondent Tucker & Associates 198 Avenue De La D' emerald Sparks, Nevada 89434-9550

Re: K023537

Trade/Device Name: Non-Sterile Powder Free Green Latex Patient Examination Gloves with Nopal/Aloe Vera/Vitamin E and Donning Aid Coating, and With Protein Labeling Claim (<50uG/G) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: September 16, 2003 Received: September 17, 2003

Dear Ms. Tucker:

This letter corrects our substantially equivalent letter of November 20, 2003 regarding the address.

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 (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 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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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 continue 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 and additionally Part 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]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number [phone] or at [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

QurLs

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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K023537

## APPENDIX N

## 510(k) SUMMARY FOR:

## NON-STERILE POWDER FREE GREEN LATEX PATIENT EXAMINATION GLOVES WITH NOPAL/ALOE VERA/VITAMIN E AND DONNING AID COATING, AND WITH PROTE LABELING CLAIM (<50ug/them)

## Contact person : Cheah Chor Hee

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 GREEN LATEX PATIENT EXAMINATION GLOVES WITH NOPAL/ALOE VERA/VITAMIN E

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-D3578-01a22 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-D3578-01ar2 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 D3578-01ae2 | SGMP |
|-------------|--------|---------------------------------|--------------|
| X-Small | | 70 mm +/- 10 mm | 70 - 75 mm |
| Small | | 80 mm +/- 10mm | 80 - 85 mm |
| Medium | | 95 mm +/- 10mm | 95 - 97 mm |
| Large | | 111mm +/- 10mm | 105 - 111 mm |
| Length | | 230 mm minimum<br>for all sizes | 242mm |
| Thickness - | Finger | 0.08mm min | 0.08 mm min |
| | Palm | 0.08mm min | 0.08 mm min |

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K023537

| | TENSILE STRENGTH | | ULTIMATE ELONGATION | |
|----------------------------------------------------|-----------------------|------------------------------|-----------------------|--------------------------|
| | ASTM-D3578-01aE2 SGMP | SGMP | ASTM-D3578-01aE2 SGMP | SGMP |
| Before Aging | Mpa<br>14.0 | Mpa | %<br>700 | % |
| X-Small<br>Small<br>Medium<br>Large | | 22.0<br>22.8<br>24.7<br>23.5 | | 770<br>790<br>830<br>820 |
| After Aging<br>X-Small<br>Small<br>Medium<br>Large | 14.0 | 25.4<br>25.2<br>25.6<br>24.3 | 500 | 860<br>810<br>860<br>840 |

## 2. Physical Properties (ASTM-D3578-01aE2 Standard Specification for Latex Exam Gloves) on Lot# 2206

## 3. Water Tight Test

Using the FDA specified 1,000 ml water leak test, 1.25 pieces of each size of the gloves were tested and our results are as given below:

| LOT # | SIZE | SAMPLE SIZE | LEAK STATUS | NUMBER<br>LEAKED |
|---------|---------|-------------|-------------|------------------|
| UN-AGED | | | | |
| 2206 | X-Small | 125 | Yes | 1 |
| 2206 | Small | 125 | No | 0 |
| 2206 | Medium | 125 | Yes | 1 |
| 2206 | Large | 125 | Yes | 2 |
| AGED | | | | |
| 2206 | X-Small | 125 | No | 0 |
| 2206 | Small | 125 | Yes | 1 |
| 2206 | Medium | 125 | Yes | 2 |
| 2206 | Large | 125 | Yes | 1 |

FDA/ASTM D3578-01aE2 requirements for latex exam The above figures are within the gloves of 2.5% AQL.

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#### Biocompatibility 4.

The bio-compatibility test results are as per Appendix M which shows that the gloves passed the tests in question.

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

| TESTS | FDA INTERNAL<br>REQUIREMENT | SGMP's |
|------------------------------------------------|-----------------------------|------------------------------------------------|
| Residual Powder<br>Content<br>(ASTM D 6124-01) | 2 mg/glove max | Range: 0.5-0.8mg/glove<br>Mean : 0.63 mg/glove |
| Presence of Cornstarch | Negative | Negative |

## 6. Residual Protein Level

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## Conclusion:-

The data presented indicate that the Powder Free latex examination glove

- meets/exceeds ASTM- D3578-01az2 Standard Specification for Latex Examination Gloves ..............................................................................................................................................................................
- . . meets FDA pinhole requirements,
- 3. meets FDA claim criterion of a powder free glove.
- 4. meets the protein labeling claim level at <50 µg/g.

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# INDICATIONS FOR USE

| APPLICANT: | SGMP COMPANY LIMITED |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) NUMBER: | K023537 |
| DEVICE NAME: | NON-STERILE POWDER FREE<br>GREEN LATEX PATIENT<br>EXAMINATION GLOVES WITH<br>NOPAL/ALOE VERA/VITAMIN E<br>AND DONNING AID COATING, AND<br>WITH PROTEIN LABELING CLAIM<br>(< 50uG/G) |

A 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | Susanne F. Barre D |
|----------------|-----------------------------------------------|
| | (Division Sign-Off) |
| | Division of Anesthesiology, General Hospital, |
| | Infection Control, Dental Devices |
| 510(k) Number: | K023537 |

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use<br>(Optional Format 1-2-96) |
|------------------------------------------|----|--------------------------------------------------|
|------------------------------------------|----|--------------------------------------------------|