NON-STERILE POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH ALOE VERA AND VITAMIN E

K013288 · Sgmp Co., Ltd. · LYY · Dec 3, 2001 · General Hospital

Device Facts

• Record ID: K013288
• Device Name: NON-STERILE POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH ALOE VERA AND VITAMIN E
• Applicant: Sgmp Co., Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Dec 3, 2001
• 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

Non-sterile, powder-free green latex examination gloves coated with Aloe Vera and Vitamin E. Used by healthcare personnel in clinical settings as a protective barrier to prevent cross-contamination between the wearer and the patient. Device functions as a physical barrier; manufactured to meet ASTM D3578-00 standards for latex examination gloves. Provides protection through material integrity; tested for water tightness (pinholes), tensile strength, and elongation. Residual powder content is minimized to meet powder-free claims; protein levels are controlled to <50 µg/g. Benefits include reduced risk of contamination during patient examinations and potential skin conditioning from Aloe Vera and Vitamin E additives.

Clinical Evidence

Bench testing only. Includes physical property testing (tensile strength, elongation), water leak testing (1,000 ml leak test), biocompatibility testing, residual powder content (ASTM D6124-00), and residual protein level testing (ASTM D5712-95). All results met or exceeded ASTM D3578-00 requirements.

Technological Characteristics

Latex examination glove; powder-free; contains Aloe Vera and Vitamin E. Dimensions and physical properties comply with ASTM D3578-00. Residual powder content <2 mg/glove (ASTM D6124-00). Residual protein level <50 µg/g (ASTM D5712-95).

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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K013288

APPENDIX M

DEC 3 - 2001

## 510(k) SUMMARY

SUMMARY OF THE SAFETY AND EFFECTIVENESS FOR POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH ALOE VERA & VITAMIN E

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 EXAM GLOVES WITH ALOE VERA & VITAMINE WITH PRODUCTION LABELING CLAIM (450 Micros

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-D3578-00 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-D3578-00 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:

| DIMENSION | ASTM D3578-00 | SGMP |
|-------------------------------------|-----------------------------------------------------------------------|--------------------------------------------------------|
| X-Small<br>Small<br>Medium<br>Large | 70 mm +/- 10 mm<br>80 mm +/- 10mm<br>95 mm +/- 10mm<br>111mm +/- 10mm | 70 - 75 mm<br>80 - 85 mm<br>90 - 97 mm<br>105 - 111 mm |
| Length | 230 mm minimum<br>for all sizes | 252mm |
| Thickness -<br>Finger<br>Palm | 0.08mm min<br>0.08mm min | 0.08 mm min<br>0.08 mm min |

### 1. Dimension

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| | TENSILE STRENGTH | | ULTIMATE ELONGATION | |
|-----------------------------------------------------|------------------|-------------------------------------|---------------------|-------------------------------|
| | ASTM-D3578-00 | SGMP | ASTM-D3578-00 | SGMP |
| Before Aging<br>X-Small<br>Small<br>Medium<br>Large | Mpa<br>14.0 | Mpa<br>25.8<br>27.8<br>27.9<br>27.1 | %<br>700 | %<br>830<br>920<br>900<br>950 |
| After Aging<br>X-Small<br>Small<br>Medium<br>Large | 14.0 | 24.1<br>27.0<br>28.7<br>25.6 | 500 | 950<br>910<br>910<br>910 |

# 2. Physical Properties (ASTM-D3578-00 Standard Specification for Latex Exam Gloves) on Lot# 1186

## 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 #<br>1186 | SIZE | SAMPLE SIZE | LEAK STATUS | NUMBER<br>LEAKED |
|-----------------|---------|-------------|-------------|------------------|
| UN-AGED | X-Small | 125 | Yes | 1 |
| | Small | 125 | No | 0 |
| | Medium | 125 | Yes | 1 |
| | Large | 125 | Yes | 2 |
| AGED | X-Small | 125 | No | 0 |
| | Small | 125 | Yes | 1 |
| | Medium | 125 | Yes | 2 |
| | Large | 125 | No | 0 |

The above figures are within the gloves of 2.5% AQL.

FDA/ASTM D3578-00 requirements for latex exam

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#### Biocompatibility 4.

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

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

| TESTS | FDA INTERNAL<br>REQUIREMENT | SGMP's |
|------------------------------------------------|-----------------------------|------------------------------------------------|
| Residual Powder<br>Content<br>(ASTM D 6124-00) | 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

| TESTS | FDA ALLOWABLE LEVEL | CLAIMED LEVEL |
|----------------|---------------------|---------------|
| ASTM D 5712-95 | < 50 µg/g | < 50 µg/g |

## Conclusion:- -

The data presented indicate that the Non-sterile Powder Free Green latex examination glove with Aloe Vera & Vitamin E

- 1. meets/exceeds ASTM- D3578-00 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 claim level at <50 µg/g.

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Image /page/3/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. Inside the circle is a stylized image of an eagle.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CEC 3 - 2001

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

Re: K013288

Trade/Device Name: Non-Sterile Powder Free Green Latex Examination Gloves with Vitamin E and Aloe Vera, Protein Labeling Claim ( 50 micrograms or Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: September 28, 2001 Received: October 2, 2001

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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Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DX 3 issualles or a basevice complies with other requirements mean that ITDA has made a decemmations administered by other Federal agencies. of the Act of ally I edelar statues and regareers, including, but not limited to: registration You must comply with an the Piece requires (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 607), laceling (21 CFR Pat 820), and if requirents as set form in the quality by overly browns (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 This letter will anow you to organ marketing of substantial equivalence of your device to 510(K) premarket notheation: "110 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 IT you desire specific ad not 10. Jour in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and Office of Colliphance at [phone] contact the Office of Compliance at [phone]. advertising or your and the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under noutheation (21 OF ICP and of Small Manufacturers, International and the Act may be obtained its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/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 Radiological Health

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# INDICATION FOR USE STATEMENT

Applicant : SGMP Company Limited

510K NUMBER :

Device Name : Non-sterile Powder Free Green Latex Examination Gloves with Aloe Vera and Vitamin E , Profess Labeling

Indication 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)

Prescription Use ......... Per 21 CFR 801.109

OR

Over-The-Counter ................

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(Division Sign-Off) Division of Dental, Infection Control, and General Hospital,Dev 510(k) Number _