POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVE

K101799 · Wear Safe (Malaysia) Sdn. Bhd. · LYY · Sep 3, 2010 · General Hospital

Device Facts

• Record ID: K101799
• Device Name: POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVE
• Applicant: Wear Safe (Malaysia) Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Sep 3, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Powder Free Natural Rubber Latex Examination Gloves, Blue Color, Non-Sterile is a disposable device intended for medical purposes that is intended to be worn on the hand for medical purposes to provide barrier against potentially infectious materials and other contaminants.

Device Story

Disposable natural rubber latex examination glove; blue color; non-sterile. Worn on hands by healthcare personnel to provide barrier protection against infectious materials and contaminants. Manufactured to meet ASTM D3578 standards. Device is a passive barrier; no electronic or mechanical components. Used in clinical settings for patient examination. Benefits patient and provider by reducing cross-contamination risk.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing against ASTM standards (D3578, D412, D5151, D6124, D5712) and biocompatibility testing (ASTM F720-81, 16CFR Part 1500).

Technological Characteristics

Natural rubber latex material. Meets ASTM D3578 (dimensions), ASTM D412 (physical properties), ASTM D5151 (pinholes), ASTM D6124 (powder residue), and ASTM D5712 (soluble protein). Biocompatibility: ASTM F720-81 (dermal sensitization) and 16CFR Part 1500 (skin irritation). Non-sterile. Protein labeling claim: ≤ 50 micrograms/dm².

Indications for Use

Indicated for use as a disposable, non-sterile, natural rubber latex barrier glove worn on the hand for medical purposes to protect against infectious materials and contaminants. Suitable for over-the-counter use.

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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K100799/5001

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

#### 1.0 Submitter:

ર

++

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

Telephone No .: [phone] Fax No.: [phone]

### 2.0 Contact Person:

# - SEP 3 2010

| Contact: | Mr. Mohd Azlan |
|----------------|---------------------|
| E-mail: | [e-mail] |
| Telephone No.: | [phone] |
| Fax No.: | [phone] |

### 3.0 Name of Device:

| Trade Name: | Powder Free Natural Rubber Latex Examination Gloves, Blue Color, Non-Sterile |
|----------------------|------------------------------------------------------------------------------|
| Common Name: | Patient Examination Glove |
| Classification Name: | Patient Examination Glove. |

## Identification of The Legally Marketed Device: 4.0

Powder Free Natural Rubber Latex Examination Gloves, Blue Color, Non-Sterile Class I Patient Examination gloves, 80LYY, meets all of the requirements of ASTM D3578 Standard Specification for Rubber Examination Gloves.

#### Description of Device: 5.0

Powder Free Natural Rubber Latex Examination Gloves, Blue Color, Non-Sterile will meet all the current specification for ASTM D3578.

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

Page 1 of 3

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## Intended Use of the Device: 6.0

i

Powder Free Natural Rubber Latex Examination Gloves, Blue Color, Non-Sterile is a disposable device intended for medical purposes that is intended to be worn on the hand for medical purposes to provide barrier against potentially infectious materials and other contaminants.

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

Powder Free Natural Rubber Latex Examination Gloves, Blue Color, Non-Sterile possesses the following technological characteristic (as compared to ASTM or equivalent standards):

| Characteristic | Standards | Device Performance |
|----------------------------|---------------------------------------------------------|-------------------------------|
| Dimensions | ASTM D3578 - 05 | Meets |
| Physical Properties | ASTM D 412 - 06ae1 | Meets |
| Freedom from pin-<br>holes | ASTM D 5151 - 06 | Meets |
| Powder Free Residue | ASTM D 6124 - 06 | Meets |
| Soluble Protein Level | ASTM D 5712 - 05 | Meets |
| Biocompatibility | Dermal Sensitization<br>(as per ASTM F720-81) | Not a contact skin sensitizer |
| | Primary Skin Irritation Test<br>(as per 16CFR Part1500) | 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 examination gloves.

Lot 13726, Jalan Haji Salleh, Batu 5½ Off Jalan Meru, 41050 Klang, Selangor Darul Ehsan Malaysia. Tel: [phone], Fax: [phone]

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### 10.0 Conclusion

It can be concluded that the Powder Free Natural Rubber Latex Examination Gloves, Blue Color, Non-Sterile 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.

Prepared By : Mohd Azlan

Date : May 18, 2010

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

Page 3 of 3

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

· Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Mohd Azlan Quality Assurance Manager Wear Safe (Malaysia) SDN. BHD. Lot PT 13726, Jalan Haji Salleh, Off Jalan Meru Klang, Selangor Darul Ehsan Malaysia 41050

### 2010 SEP 3

# Re: K101799

Trade/Device Name: Powder Free NR Latex Examination Gloves Blue (Colored), Non-Sterile, with Protein Labeling claim of 50 micrograms per dm of glove or less of water soluble protein.

Regulation Number: 21 CFR 880.6250

Regulation Name: Patient Examination Glove

Regulatory Class: I

Product Code: LYY

Dated: August 20, 2010

Received: August 24, 2010

Dear Mr. Azlan:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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. Azlan

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 go to .

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor.You/Industry/default.htm.

Sincerely vours.

Anthony D. Watson, B.S., M.S., M.B.A.

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

K 101799/5001

# INDICATIONS FOR USE

| Applicant: | WEAR SAFE (MALAYSIA) SDN. BHD. | SEP 3 2010 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510(k) Number (if known): | | |
| Device Name: | Powder Free NR Latex Examination Gloves Blue (Colored),<br>Non-Sterile, with Protein Labeling claim of 50 micrograms per<br>dm² of glove or less of water soluble protein. | |
| Indication For Use: | A powder free latex examination glove is a disposable device<br>made of natural rubber material intended to be worn on the<br>hand for medical purposes to provide barrier against potentially<br>infectious materials and other contaminants. | |

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (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)

Elizabeth &, Mamie-Williams

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

510(k) Number: K101799 Page 1 of 1

Lot 13726, Jalan Haji Salleh, Batu 5½ Off Jalan Meru, 41050 Klang, Selangor Darul Ehsan Malaysia. Tel: [phone], Fax: [phone]