NON-STERILE POWDERED GREEN COLORED POWDERED LATEX PATIENT EXAMINATION GLOVES WITH & WITHOUT SOUR/APPLE/PEPPERMINT SCENTS

K030993 · Sgmp Co., Ltd. · LYY · Jun 12, 2003 · General Hospital

Device Facts

• Record ID: K030993
• Device Name: NON-STERILE POWDERED GREEN COLORED POWDERED LATEX PATIENT EXAMINATION GLOVES WITH & WITHOUT SOUR/APPLE/PEPPERMINT SCENTS
• Applicant: Sgmp Co., Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Jun 12, 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, powdered, green-colored latex patient examination gloves; available with or without sour apple or peppermint scents. Device functions as a physical barrier to prevent cross-contamination between patient and examiner. Manufactured with a protein labeling claim of <200 µg/g. Used in clinical settings by healthcare professionals. Provides protection during patient examinations.

Clinical Evidence

Bench testing only. Testing included physical properties (tensile strength, ultimate elongation) per ASTM D-3578-01aE2, water-tightness testing (AQL 2.5%), and residual protein level testing per ASTM D-5712-99 (mean 112 µg/g, range 91–123 µg/g). Biocompatibility testing was performed with passing results.

Technological Characteristics

Latex material; powdered; green color; optional sour apple or peppermint scents. Dimensions and physical properties conform to ASTM D-3578-01aE2. Protein content <200 µg/g per ASTM D-5712-99. Non-sterile.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's 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.

Predicate Devices

• K000671

Submission Summary (Full Text)

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JUN 1 2 2003

Appendix I, Page 1 (added)

## 510(k) SUMMARY FOR

## K030993

## NON-STERILE GREEN COLORED POWDERED LATEX PATIENT EXAMINATION GLOVES WITH & WITHOUT SOUR APPLE/PEPPERMINT SCENTS AND WITH A PROTEIN LABELING CLAIM (<200ug/g)

Contains 200 migm or less of for at Water Extractable

Submitted for: SGMP COMPANY, LTD.

| Submitted by: | TUCKER & ASSOCIATES<br>Official Correspondent for SGMP COMPANY, LTD.<br>JANNA P. TUCKER, President – CEO<br>198 Avenue de la D'emerald<br>Sparks, NV 89434-9550<br>Phone: [phone]<br>Fax: [phone]<br>E-Mail: [e-mail] |
|---------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

This device is substantially equivalent to K000671, which is another of SGMP's Colored, and/or scented powdered latex gloves with protein labeling (<200ug/g).

Revised 06-04-03

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| LOT # | TENSILE STRENGTH | | ULTIMATE ELONGATION | |
|---------|------------------|-----------|---------------------|-----------|
| 0238 | UNAGED | AGED | UNAGED | AGED |
| TESTED | SGMP ASTM | SGMP ASTM | SGMP ASTM | SGMP ASTM |
| X-SMALL | 22.6 14.0 | 20.8 14.0 | 820 700 | 950 500 |
| SMALL | 21.9 14.0 | 22.5 14.0 | 920 700 | 920 500 |
| MEDIUM | 21.7 14.0 | 22.8 14.0 | 970 700 | 880 500 |
| LARGE | 21.3 14.0 | 20.7 14.0 | 950 700 | 896 500 |

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

#### 3. Water Tight Test Data

| BATCH<br>NUMBER | DATE<br>TESTED | SAMPLING SIZE | LEAK<br>STATUS | NUMBER<br>LEAKED |
|---------------------------------------|----------------|--------------------------|-------------------------|------------------|
| Unaged Smpl<br>0238 XS<br>S<br>M<br>L | 10 Feb 03 | 125<br>125<br>125<br>125 | No<br>Yes<br>Yes<br>Yes | 0<br>1<br>2<br>1 |
| Aged Smpl<br>0238 XS<br>S<br>M<br>L | 18 Feb 03 | 125<br>125<br>125<br>125 | No<br>Yes<br>Yes<br>Yes | 0<br>1<br>2<br>1 |

The above figures are within the ASTM D-3578-01aE2 requirements for latex exam gloves of 2.5% AQL.

#### 4. Biocompatibility

:

## BIOCOMPATIBILITY TESTS

Test results indicate that the gloves the passed biocompatibility tests for gloves.

### 5. Residual Protein Level

| TESTS | FDA ALLOWABLE LEVEL | CLAIMED LEVEL |
|----------------|---------------------|------------------------------------------------------|
| ASTM D 5712-99 | | < 200 µg/g<br>Range: 91 – 123 µg/g<br>Mean: 112 µg/g |

Revised 5-28.03

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract image of an eagle's head with three stripes representing the feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

JUN 1 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K030993

Trade/Device Name: Non-Sterile Powdered Green Colored Powdered Latex Patient with or without Sour Apple, Peppermint Scents, Contains 200 Micrograms or Less of Total Extractable Protein Per Gram Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: May 28, 2003 Received: May 29, 2003

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 (OS) 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.

Pattico Cusentiffoce

Susan Runner, DDS, MA Interim 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.

1030993

# 510(k) NUMBER:

# DEVICE NAME:

# NON-STERILE GREEN COLORED POWDERED LATEX PATIENT EXAMINATION GLOVES WITH & WITHOUT SOUR APPLE/PEPPERMINT SCENTS A WITH A PROTEIN LABELI (<200uG/G) Contains 200 mg setractable profein per

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Olin S. Lim
(Division Sign-Off)

ion of Anesthesiology, General Hospital, ntrol, Dental Devices

Prescription Use (Per 21 CFR 801.109)

510(k) Number: K030993

OR Over-The-Counter Use

(Optional Format 1-2-96)

Revised 06-04-03