POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTER

K050529 · Spi Gloves Sdn. Bhd. · LYY · Mar 16, 2005 · General Hospital

Device Facts

• Record ID: K050529
• Device Name: POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTER
• Applicant: Spi Gloves Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Mar 16, 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

Polymer-coated, powder-free latex examination glove; disposable; worn on examiner's hands or fingers. Functions as a physical barrier to prevent cross-contamination between patient and examiner in medical settings. Manufactured to meet ASTM D3578-01a requirements for watertight integrity, physical dimensions, and tensile strength. Protein content labeled as 50 micrograms or less per gram. Used by healthcare professionals during patient examinations.

Clinical Evidence

Bench testing only. Performance data demonstrates compliance with ASTM D3578-01a standards, including 1000 ml watertight testing, physical dimensions, tensile strength (21.1 MPa before aging, 16.7 MPa after aging), and ultimate elongation. Powder content is <2mg/glove; protein content is <50 micrograms/gram. Biocompatibility testing included primary dermal irritation and guinea pig sensitization (Buehler test), which the device passed.

Technological Characteristics

Latex patient examination glove; polymer-coated; powder-free. Meets ASTM D3578-01a standards. Physical properties: tensile strength >14.0 MPa, elongation >650% (before aging). Thickness >0.10 mm. Biocompatible per 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)

{0}------------------------------------------------

K050529

The The Career Friders

# MA 16 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 8, 2005 |
| 3.0 | Name of Device | |
| | Device Name | Polymer Coated Powder Free Latex Examination<br>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, powder free that meets all the requirements of ASTM Standard D3578-01 a 22 and FDA requirements.

#### 5.0 Description of The Device

Class 1 Latex Patient Examination Glove 80LYY, powder free that 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.

{1}------------------------------------------------

KC 50509

## SPI GLOVES SDN. BHD.

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

#### Summary of Performance Data: רי

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

| | | POLYMER COATED POWDER FREE LATEX EXAM GLOVES | |
|----------------------------------------------------------------------|------------------------------|----------------------------------------------|----------|
| TEST | ASTM D3578-01aE2<br>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<br>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><br>Finger | Min 0.08 | 0.10 minimum | |
| Palm | Min 0.08 | 0.10 minimum | |
| 5. Physical Properties<br><br>Before Aging<br>Tensile Strength (Mpa) | Min 14.0 | *21.1 | |
| Ultimate Elongation (%) | Min 650 | *817 | |
| After Aging<br>Tensile Strength (Mpa) | Min 14.0 | *16.7 | |
| Ultimate Elongation (%) | Min 500 | *758 | |
| 6. Powder Content | - | Below 2mg / glove | |
| 7. Protein Content | - | Below 50 microgram / gram | |

* The average result obtained from Attachment C.

{2}------------------------------------------------

Ki 50529

## 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" 8. Standard and FDA's requirement. Powder content is below 2mg per glove, which meet the FDA Requirements.
- The Biocompatibility Test consists of Primary Dermal Irritation Test and Guinca 9. Pig Sensitization (Buehler) test. The gloves pass the Biocompatibility Tests.
- 10. Conclusion

We concluded that the Polymer Coated Powder Free Latex Examination Gloves meet the below specifications:

- ASTM D3578-01a42 Standard -
- FDA pinhole requirements -
- ** FDA minimum powder residual content

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.

MAR 16 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: K050529

Trade/Device Name: Polymer Coated Powder Free Latex Examination Gloves With Protein Labeling Claim (Contains 50 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 Scction 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.

{4}------------------------------------------------

Page 2 - Ms. Chooi Fong

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisod that 1 DTC issultion on that your device complies with other requirements Incall that I DA has made a dotes and regulations administered by other Federal agencies. of the Act of ally I ederal battle and surface and submitted to: registration 1 our must comply with an are neveling (21 CFR Part 801); good manufacturing practice aller listing (21 CFR Part 807), labeling systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the qualify ijon 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) This letter will anow yourse bogal finding of substantial equivalence of your device to a premiarket notified.com- The PDF 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), If you desire specific at 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 may obtain of Small Manufacturers, International and Consumer Assistance at its toll-frec number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

{5}------------------------------------------------

# INDICATIONS FOR USE STATEMENT

: SPI Gloves Sdn. Bhd. Applicant

| 510(K) Number: | K050529 |
|----------------|---------|
|----------------|---------|

: Polymer Coated Powder Free Latex Examination Gloves With Device Name Polymer Coated Fowder Proc Eater Enans 50 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 worn A patient examiliation glove is a disposable device mission between patient and examiner.
on the examiner's hands or finger to prevent contamination between patient and exami

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

AND/OR

Over-The-Counter ..................... (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 H. Misselewitz 3/16/05

Control, Dental Devices
K080529