NON-STERILE ORANGE COLORED POWDERED LATEX PATINET EXAMINATION GLOVES WITH & WITHOUT ORANGE/VANILLA SCENTS

K030994 · Sgmp Co., Ltd. · LYY · Jun 12, 2003 · General Hospital

Device Facts

• Record ID: K030994
• Device Name: NON-STERILE ORANGE COLORED POWDERED LATEX PATINET EXAMINATION GLOVES WITH & WITHOUT ORANGE/VANILLA 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 latex examination gloves; orange-colored; available with or without orange/vanilla scents. Device functions as a physical barrier to prevent cross-contamination between patient and examiner. Used in clinical settings by healthcare professionals. Provides protection through material properties; meets ASTM D-3578-01aE2 standards for tensile strength, elongation, and water-tightness. Features a protein labeling claim of <200 µg/g total water-extractable protein to reduce potential for latex sensitivity.

Clinical Evidence

Bench testing only. Includes physical property testing (tensile strength, ultimate elongation) per ASTM D-3578-01aE2, water-tight leak testing (AQL 2.5%), and biocompatibility testing. Residual protein levels verified via ASTM D 5712-99, with a mean of 101 µg/g.

Technological Characteristics

Material: Latex. Physical properties meet ASTM D-3578-01aE2. Protein content: <200 µg/g (ASTM D 5712-99). Form factor: Powdered, orange-colored, scented (orange/vanilla) or unscented. Non-sterile.

Indications for Use

Indicated for use as a disposable medical device worn on the examiner's hand or finger to prevent contamination between patient and examiner. Suitable for general patient examination settings.

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

## K030994

## NON-STERILE ORANGE COLORED POWDERED LATEX PATIENT EXAMINATION GLOVES WITH & WITHOUT ORANGE/VANILLA SCENTS AND WITH A PROTEIN LABELING CLAIM (<200ug/g),

Contains 200 megm on less of fotal Waker extrac per greem . profesn

SGMP COMPANY, LTD. Submitted for:

Submitted by: TUCKER & ASSOCIATES Official Correspondent for SGMP COMPANY, LTD. JANNA P. TUCKER, President - CEO 198 Avenue de la D'emerald Sparks, NV 89434-9550 Phone: [phone] Fax: [phone] 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

JC

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Appendix I

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

| LOT # | TENSILE STRENGTH | | | | ULTIMATE ELONGATION | | | |
|-------------------|------------------|------|------|------|---------------------|------|------|------|
| | UNAGED | | AGED | | UNAGED | | AGED | |
| 0226 | | | | | | | | |
| TESTED<br>X-SMALL | SGMP | ASTM | SGMP | ASTM | SGMP | ASTM | SGMP | ASTM |
| | 24.1 | 14.0 | 27.0 | 14.0 | 820 | 700 | 900 | 500 |
| SMALL | 24.8 | 14.0 | 24.4 | 14.0 | 830 | 700 | 870 | 500 |
| MEDIUM | 25.8 | 14.0 | 24.2 | 14.0 | 820 | 700 | 890 | 500 |
| LARGE | 22.4 | 14.0 | 21.0 | 14.0 | 800 | 700 | 820 | 500 |

## 3. Water Tight Test Data

| BATCH<br>NUMBER | DATE<br>TESTED | SAMPLING SIZE | LEAK<br>STATUS | NUMBER<br>LEAKED |
|------------------------|----------------|---------------|----------------|------------------|
| Unaged Smpl<br>0226 XS | 10 Feb 03 | 125 | Yes | 1 |
| S | | 125 | No | 0 |
| M | | 125 | Yes | 1 |
| L | | 125 | Yes | 1 |
| Aged Smpl<br>0226 XS | 18 Feb 03 | 125 | No | 0 |
| S | | 125 | Yes | 1 |
| M | | 125 | Yes | 2 |
| L | | 125 | No | 0 |

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

## 4. Biocompatibility

BIOCOMPATIBILITY TESTS

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

## 5. Residual Protein Level

| TESTS | FDA ALLOWABLE LEVEL | CLAIMED LEVEL |
|----------------|---------------------|----------------------------------------------------|
| ASTM D 5712-99 | - | < 200 µg/g<br>Range: 98–112 µg/g<br>Mean: 101 µg/g |

Revised 5-27-03

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 2 2003

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

Re: K030994

Trade/Device Name: Non-Sterile Orange Colored Powdered Latex Examination Gloves with & without Orange/Vanilla Scents and with a Protein Labeling Claim. Contains 200 Micrograms or Less of Total Water Extractable Protein Per Gram Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: May 27, 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 (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.

Patricio Cussenhoffer

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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#### PAGE 02/03

# INDICATIONS FOR USE

# APPLICANT:

SGMP COMPANY, LTD.

1030994

# 510(k) NUMBER:

# DEVICE NAME:

# NON-STERILE ORANGE COLORED POWDERED LATEX PATIENT EXAMINATION GLOVES WITH & WITHOUT ORANGE/VANILLA SCENTS AND WITH A PROTEIN LABELING CLAIM (<200uG/G) Umfars

over sytractable profess per gram Wall : q to fal OR less 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)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use_

(Optional Format 1-2-96)

Chiu S. Lin

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental De

510(k) Number

Revised 06-04-0