POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABL

K050527 · Spi Gloves Sdn. Bhd. · LYY · Mar 18, 2005 · General Hospital

Device Facts

• Record ID: K050527
• Device Name: POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABL
• Applicant: Spi Gloves Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Mar 18, 2005
• 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 hands or finger to prevent contamination between patient and examiner.

Device Story

Disposable powdered latex examination glove; worn on hands/fingers by healthcare personnel; acts as physical barrier to prevent cross-contamination between patient and examiner; used in clinical/medical settings; provides protection during examinations; manufactured from latex with absorbable dusting powder.

Clinical Evidence

Bench testing only. Performance data includes watertight testing (1000 ml), physical dimensions (length, palm width, thickness), physical properties (tensile strength and ultimate elongation before/after aging), powder content (<10 mg/dm2), and protein content (<200 µg/dm2). Biocompatibility testing included primary dermal irritation and Guinea Pig sensitization (Buehler test).

Technological Characteristics

Material: Latex. Form factor: Disposable examination glove. Powdered with absorbable dusting powder. Meets ASTM D3578-01a22 standards. Protein content <200 µg/g. Biocompatibility: Passed primary dermal irritation and Guinea Pig sensitization tests.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hands or fingers 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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K050527

## MAR 1 8 2005

### SPI GLOVES SDN. BHD.

5, Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak Darul Ridzuan, Malaysia. e-mail: [e-mail]

### 1.0 SMDA 510 (K) SUMMARY

| 2.0 | Submitter | SPI GLOVES SDN. BHD.<br>5, Persiaran Greentown 8,<br>Greentown Business Centre<br>30450 Ipoh, Perak, Malaysia. |
|-----|--------------------------|----------------------------------------------------------------------------------------------------------------|
| | Tel | (60 5) 322 3200 |
| | Fax | (60 5) 322 2300 |
| | Name of Contact Person | Ms. CHUN CHOOI FONG |
| | Date of Summary Prepared | February 14, 2005 |
| 3.0 | Name of Device | |
| | Device Name | Powdered Latex Examination Gloves |
| | Common Name | Exam Glove |

Classification Name Latex Patient Examination Glove

#### 4.0 Identification of the Legally Marketed Devices

Class 1 Latex Patient Examination Glove 80LYY, powdered with absorbable dusting powder, which meets all the requirements of ASTM Standard D3578-01a22 and FDA requirements.

#### 5.0 Description of The Device

Class 1 Latex Patient Examination Glove 80LYY, powdered with absorbable dusting powder, which meets all the requirements of ASTM Standard D3578-01a52 and FDA Water Leak Test.

#### 6.0 The Intended Use of Glove

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

> Page 1 of 3 ATTACHMENT L

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K050527

## SPI GLOVES SDN. BHD.

5, Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak Darul Ridzuan, Malaysia. e-mail: [e-mail]

#### 7. Summary of Performance Data:

Performance data of gloves based on ASTM D3578-01a22 and FDA 1000 ml watertight test.

| TEST | ASTM D3578-01aE2 | POWDERED LATEX EXAM GLOVES | |
|------------------------------------------------------------------|------------------|------------------------------|---------------------------|
| | AQL=2.5% | Pass GI | AQL=2.5% |
| 1. Watertight (1000 ml) | GI | | |
| 2. Length (mm)<br>Size XS | Min 230 | 240 mm minimum for all sizes | |
| S | Min 230 | | |
| M | Min 230 | | |
| L | Min 230 | | |
| XL | Min 230 | | |
| 3. Palm width (mm)<br>Size XS | - | | <80 mm |
| S | 80 +/- 10 | | 85 +/- 3 mm |
| M | 95 +/- 10 | | 95 +/- 3 mm |
| L | 111 +/- 10 | | 105 +/- 3 mm |
| XL | - | | >110 mm |
| 4. Thickness (mm)<br>(Single Layer)<br>Finger | Min 0.08 | | 0.10 minimum |
| Palm | Min 0.08 | | 0.10 minimum |
| 5. Physical Properties<br>Before Aging<br>Tensile Strength (Mpa) | Min 14.0 | | *28.0 |
| Ultimate Elongation (%) | Min 650 | | *982 |
| After Aging<br>Tensile Strength (Mpa) | Min 14.0 | | *26.9 |
| Ultimate Elongation (%) | Min 500 | | *970 |
| 6. Powder Content | - | | Below 10 mg / dm2 |
| 7. Protein Content | - | | Below 200 microgram / dm2 |

* The average result obtained from Attachment C.

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K050527

## SPI GLOVES SDN. BHD.

5, Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak Darul Ridzuan, Malaysia. e-mail: [e-mail]

- The performance data of the glove as showed above meet the ASTM D3578-01a"2 8. Standard and FDA's requirement. Powder content is below 10 mg per dm², which meet the FDA Requirements.
- The Biocompatibility Test consists of Primary Dermal Irritation Test and Guinea 9. Pig Sensitization (Buehler) test. The gloves pass the Biocompatibility Tests.
- 10. Conclusion

We concluded that the Powdered Latex Examination Gloves meet the below specifications:

- ASTM D3578-01a52 Standard -
- FDA pinhole requirements -
- FDA minimum powder residual content --

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes extending from its back, representing health, hope, and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

MAR 1 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Chun Chooi Fong Quality Management System Manager SPI Gloves SND. BHD. 5, Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak, Darul Ridzuan MALAYSIA

Re: K050527

Trade/Device Name: Powdered Latex Examination Gloves with Protein Labeling Claim (Contains 200 Micrograms or Less of Total Water Extractable Protein Per Gram) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: February 28, 2005 Received: March 2, 2005

Dear Ms. Chooi Fong:

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 cnactment 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. Chooi Fong

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisod that I Dr. 5 issuained on that your device complies with other requirements mean that IDA has made a deceminations administered by other Federal agencies. of the Act of ally I cucral statues and regaraters, including, but not limited to: registration 1 ou must comply with an the Hoseng (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 067), lacems (QS) regulation (21 CFR Part 820); and if requirenents as set form in the quality of other (Sections 531-542 of the Act); 21 CFR 1000-1050.

21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin mationing your substantial equivalence of your device to a premarket notification. "The PDF mailing or clossification 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), If you desire specific advice for Jour at [phone]. Also, please note the regulation presse contact the Other or Some to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general miorinational and Consumer Assistance at its toll-free Division [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Saute Michie. Oatis.

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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# INDICATIONS FOR USE

: SPI Gloves Sdn. Bhd. Applicant K050527 510(K) Number :

Device Name : Powdered Latex Examination Gloves With Protein Labeling Claim (Contains 200 micrograms or less of Total Water Extractable Protein per Gram)

Indication For Use:

A patient examination glove is a disposable device intended for medical purposes that is A patient examiner's hands or finger to prevent contamination between patient and examiner.

Prescription Use: ......................... (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter ...........X.......... (21 CFR 801 Subpart C)

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

............................................................................................................................................................................. Concurrence of CDRH, Office of Device Evaluation (ODE)

Sheila V. Murphy, L.S.

Anticlogy, General Hospital

K050527

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