POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 OF GLOVE

K090066 · Wear Safe (Malaysia) Sdn. Bhd. · KGO · May 15, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K090066
• Device Name: POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 OF GLOVE
• Applicant: Wear Safe (Malaysia) Sdn. Bhd.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: May 15, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

The Powder Free Polymer Coated Latex Surgical Gloves, Sterile, with Protein Labeling claim of 50 micrograms per dm2 of glove or less of water soluble protein is a disposable device intended for medical purposes that is intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Story

Disposable natural rubber latex surgical glove; polymer coated; powder-free. Used by operating room personnel to provide a sterile barrier protecting surgical wounds from contamination. Device performance verified against ASTM D3577 standards for dimensions, physical properties, and freedom from pinholes. Biocompatibility confirmed via ISO 10993-10 testing (non-sensitizing, non-irritant). Protein content labeled at 50 micrograms per dm2 or less.

Clinical Evidence

No clinical data; bench testing only. Performance verified against ASTM D3577, ASTM D412, ASTM D5151, and ASTM D6124. Biocompatibility testing performed per ISO 10993-10.

Technological Characteristics

Natural rubber latex; polymer coated; powder-free. Dimensions/physical properties per ASTM D3577-06 and ASTM D412-06a. Freedom from pinholes per ASTM D5151-06. Powder residue per ASTM D6124-06. Biocompatibility per ISO 10993-10. Sterile.

Indications for Use

Indicated for use by operating room personnel as a disposable barrier to protect surgical wounds from contamination.

Regulatory Classification

Identification

A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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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K090066

# Wear Safe (Malaysia) Sdn.Bhd. (Company No.204396-X)

# FDA 510(k), Premarket Notification : 510(k) Summary of Safety and Effectiveness Information

#### Submitter: 1.0

WEAR SAFE (MALAYSIA) SDN. BHD. Lot PT 13726, Jalan Haji Salleh, Off Jalan Meru, 41050 Klang, Selangor Darul Eshan, Malaysia.

[phone] Telephone No .: 4603 3392 2118 Fax No .:

#### Contact Person: 2.0

| Contact: | Mr. SH TAN |
|----------------|---------------------|
| E-mail: | [e-mail] |
| Telephone No.: | [phone] |
| Fax No.: | [phone] |

#### 3.0 Name of Device:

.

Powder Free Polymer Coated Latex Surgical Gloves, Sterile, with Trade Name: Protein Labeling claim of 50 micrograms per dm- of glove or less of water soluble protein. Surgeon's Glove Common Name: Classification Name: Surgeon's Glove

#### Identification of The Legally Marketed Device: 4.0

The Powder Free Polymer Coated Latex Surgical Gloves, Sterile, with Protein Labeling claim of 50 micrograms per dm2 of glove or less of water soluble protein, Class I surgeon's gloves, 79KGO, meets all of the requirements of ASTM D3577 Standard Specification for Rubber Surgical Gloves for Medical Application.

#### Description of Device: રું..........................................................................................................................................................................

The Powder Free Polymer Coated Latex Surgical Gloves, Sterile, with Protein Labeling claim of 50 micrograms per dm2 of glove or less of water soluble protein will meet all the current specification for ASTM D3577.

Lot 13726, Jalan Haji Salleh, Batu 5¼ Off Jalan Meru, 41050 Klang, Selangor Darul Ehsan Malaysia. Tel: [phone], Fax: [phone]

MAY 15 2009

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#### Intended Use of the Device: 6.0

The Powder Free Polymer Coated Latex Surgical Gloves, Sterile, with Protein Labeling claim of 50 micrograms per dm2 of glove or less of water soluble protein is a disposable device intended for medical purposes that is intended to be worn by operating room personnel to protect a surgical wound from contamination.

#### Summary of The Technological Characteristics of The Device: 7.0

The Powder Free Polymer Coated Latex Surgical Gloves, Sterile, with Protein Labeling claim of 50 micrograms per dm3 of glove or less of water soluble protein possesses the following technological characteristic (as compared to ASTM or equivalent standards):

| Characteristic | Standards | Device Performance |
|----------------------------|-------------------------------------------------------|-------------------------------|
| Dimensions | ASTM D3577 - 06 | Meets |
| | ASTM D 412 - 06ael | Meets |
| Freedom from pin-<br>holes | ASTM D 5151 - 06 | Meets |
| Powder Free Residue | ASTM D 6124 - 06 | Meets |
| Biocompatibility | Dermal Sensitization<br>(as per ISO 10993-10) | Not a contact skin sensitizer |
| | Primary Skin Irritation Test<br>(as per ISO 10993-10) | Not a primary skin irritant |

#### Substantial Equivalent Based on Assessment of Non-Clinical Performance Data 8.0

The performance test data that support a determination of substantial equivalence are described above.

#### Substantial Equivalent Based on Assessment of Clinical Performance Data 9.0

Clinical data are not needed for market cleared surgical gloves.

#### 10.0 Conclusion

It can be concluded that the Powder Free Polymer Coated Latex Surgical Gloves, Sterile, with Protein Labeling claim of 50 micrograms per dm2 of glove or less of water soluble protein is safe and effective for use and will perform according to the glove performance standards referenced in Section 7 above, thereby meeting ASTM standards, FDA requirements, and the labeling claims for the product.

Consequently, this device is substantially equivalent to current marketed devices.

This summary will include any other information reasonably deemed necessary by the FDA.

Lot 13726, Jalan Haji Salleh, Batu 5¼ Off Jalan Meru, 41050 Klang, Selangor Darul Ehsan Malaysia. Tel: [phone], Fax: [phone]

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized emblem. The emblem depicts a bird-like figure with three curved lines forming its body and tail, symbolizing health and human services.

### Public Health Service

MAY 15 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. SH Tan Wear Safe (Malaysia) Sdn.Bhd. Lot 13726 Jalan Haji Salleh Batu 51/4 Off Jalan Meru 41050 Klang Selangor Darul Ehsan MALAYSIA

Re: K090066

Trade/Device Name: Powder Free Polymer Coated Latex Surgical Gloves, Sterile, With Protein Labeling Claim of 50 Micrograms Per DM2 Glove Or Less Of Water Soluble Protein.

Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: April 27, 2009 Received: April 30, 2009

# Dear Mr. Tan:

We have reviewed vour 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 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- Mr. Tan

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/industry/support/index.html.

Sincerely yours,

Susan Tunner

Susan Runner, D.D.S., MA Acting 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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WSM Wear Safe (Malaysia) Sdn.Bhd. (Company No.204396-X)

# INDICATIONS FOR USE

Applicant:

# WEAR SAFE (MALAYSIA) SDN. BHD.

510(k) Number (if known):

Device Name:

Powder Free Polymer Coated Latex Surgical Gloves, Sterile, with Protein Labeling claim of 50 micrograms per dm- of glove or less of water soluble protein.

Indication For Use:

A powder free polymer coated latex surgical glove is a disposable device made of natural rubber material intended to be worn by operating room personnel to protect a surgical wound from contamination.

Prescription Use -(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shulin M. Murphy

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

510(k) Number: K090466

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Lot 13726, Jalan Haji Salleh, Batu 5¼ Off Jalan Meru, 41050 Klang, Selangor Darul Ehsan Malaysia. Tel: [phone], Fax: [phone]