NON-STERILE, POWDER FREE ORANGE LATEX EXAMINATION GLOVES W/ OR WITHOUT ORANGE/VANILLA SCENTING PLUS A PROTEIN LABELING

K032294 · Sgmp Co., Ltd. · LYY · Aug 28, 2003 · General Hospital

Device Facts

• Record ID: K032294
• Device Name: NON-STERILE, POWDER FREE ORANGE LATEX EXAMINATION GLOVES W/ OR WITHOUT ORANGE/VANILLA SCENTING PLUS A PROTEIN LABELING
• Applicant: Sgmp Co., Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Aug 28, 2003
• 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 latex examination glove; available with or without orange/vanilla scenting. Designed as a physical barrier for healthcare personnel to prevent cross-contamination during patient examinations. Manufactured to meet ASTM D-3578-01aE2 standards for latex examination gloves. Features a protein labeling claim of <50 µg/g. Used in clinical settings by healthcare professionals.

Clinical Evidence

Bench testing only. Testing included physical property evaluation (tensile strength, ultimate elongation), water-tight leak testing (1,000 ml test, 2.5% AQL), residual powder content (ASTM D 6124-01), residual protein levels (ASTM D 5712-99), and biocompatibility testing. All results met or exceeded ASTM D-3578-01aE2 specifications.

Technological Characteristics

Latex patient examination glove; powder-free; orange color; optional orange/vanilla scent. Meets ASTM D-3578-01aE2. Residual powder <2 mg/glove; residual protein <50 µg/g. Dimensions: 242mm length; 0.08mm min thickness. Non-sterile.

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.

Predicate Devices

• POWDER FREE PURPLE LATEX EXAM GLOVES WITH AND WITHOUT GRAPE SCENTING (K011370)

Submission Summary (Full Text)

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K032294

#### APPENDIX M

# 510(k) SUMMARY

#### NON-STERILE POWDER-FREE ORANGE LATEX EXAMINATION GLOVES WITH OR WITHOUT ORANGE/VANILLA SCENTING PLUS A PROTEIN LABELING CLAIM (<50uG/G) (Contains 50 grams or less of water extractable protein per gram of glove)

Submitted For: SGMP COMPANY LTD.

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 775-342-2612 Phone: [phone] Fax: Tuckerjanía aol.com E-Mail:

## Equivalent Predicate Device: POWDER FREE PURPLE LATEX EXAM GLOVES WITH AND WITHOUT GRAPE SCENTING which was approved for marketing as K011370.

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 ORANGE LATEX EXAM<br>GLOVES WITH/WITHOUT ORANGE/VANILLA<br>SCENTING AND WITH PROTEIN LABELING (<50uG/G) |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Latex Exam Gloves. |
| Classification Name: | Patient Examination Glove, Latex. |
| Classification Information<br>& Device Description: | Class I latex patient examination glove, 80LYY, powder free<br>And meeting all the requirements of ASTM D-3578-01aE2,<br>Standard Specification for Latex Examination Gloves for<br>Medical Application. |
| Intended Use of Device: | A medical glove to be worn on the hand of the health care and<br>similar personnel to prevent contamination between health<br>care personnel and the patient. |

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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 | 90 - 97 mm |
| Large | 111mm +/- 10mm | 105 - 111 mm |
| Length | 230 mm minimum<br>for all sizes | 242mm |
| Thickness -<br>Finger<br>Palm | 0.08mm min<br>0.08mm min | 0.08 mm min<br>0.08 mm min |

- 2. Physical Properties (ASTM-D3578-01aE2 Standard Specification for Latex Exam Gloves)
on Lot# 0324

| | TENSILE STRENGTH | | ULTIMATE ELONGATION | |
|-----------------------------------------------------|------------------|-------------------------------------|---------------------|-------------------------------|
| | ASTM-D3578-01aE2 | SGMP | ASTM-D3578-01aE2 | SGMP |
| Before Aging<br>X-Small<br>Small<br>Medium<br>Large | Mpa<br>14.0 | Mpa<br>22.0<br>28.1<br>30.2<br>24.3 | %<br>700 | %<br>800<br>850<br>900<br>810 |
| After Aging<br>X-Small<br>Small<br>Medium<br>Large | 14.0 | 25.4<br>28.3<br>26.2<br>24.6 | 500 | 800<br>830<br>830<br>800 |

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# 3. Water Tight Test

| BATCH # | SIZE | SAMPLE SIZE | LEAK STATUS | NUMBER LEAKED |
|---------|---------|-------------|-------------|---------------|
| UN-AGED | | | | |
| 0324 | X-Small | 125 | Yes | 1 |
| 0324 | Small | 125 | No | 0 |
| 0324 | Medium | 125 | Yes | 1 |
| 0324 | Large | 125 | No | 0 |
| AGED | | | | |
| 0324 | X-Small | 125 | Yes | 1 |
| 0324 | Small | 125 | No | 0 |
| 0324 | Medium | 125 | Yes | 1 |
| 0324 | Large | 125 | Yes | 1 |

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:

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

#### 4. Biocompatibility

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 6124-01) | 2 mg/glove max | Range: 0.5-0.9mg/glove<br>Mean : 0.7 mg/glove |
| Presence of Cornstarch | Negative | Negative |

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# 6. Residual Protein Level

| TESTS | FDA ALLOWABLE LEVEL | CLAIMED LEVEL |
|----------------|---------------------|---------------|
| ASTM D 5712-99 | < 50 µg/g | < 50 µg/g |

# Conclusion:-

The data presented indicate that the Non-sterile Powder Free Orange latex examination glove with Orange/Vanilla Scenting

- 1. meets/exceeds ASTM- D3578-01aE2 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/4/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.

Public Health Service

AUG 2 8 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K032294

Trade/Device Name: Non-Sterile Powder-Free Orange Latax Examination Glove with or without Orange/Vanilla Scenting Plus a Protein Labeling Claim (<50uG/G) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: July 23, 2003 Received: July 25, 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.

Susan Runner

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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# INDICATION FOR USE STATEMENT

Applicant : SGMP Company Limited

K032294 510K NUMBER :

Device Name : Non-sterile Powder Free Orange Latex Examination Gloves with or without Orange/Vanilla Scenting PLUSS A PROTENAL grans on Ress of for fas water Contains of the 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.

Qim S. Lim

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

510(k) Number: K032294

Concurrence of CDRH Office of Device Evaluation (ODE)

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

OR

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