POWDER FREE LATEX PATIENT EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM

K112612 · Top Calibre Sdn Bhd · LYY · Jan 18, 2012 · General Hospital

Device Facts

• Record ID: K112612
• Device Name: POWDER FREE LATEX PATIENT EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM
• Applicant: Top Calibre Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Jan 18, 2012
• 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 hand to prevent contamination between patient and examiner.

Device Story

Disposable latex patient examination glove; worn on examiner's hand; prevents contamination between patient and examiner. Features protein content labeling claim (≤50 micrograms/dm² water extractable protein). Manufactured to meet ASTM D3578-05 (2010) standards for physical properties, dimensions, and freedom from pinholes. Used in clinical settings by healthcare providers. Provides barrier protection.

Clinical Evidence

No clinical data. Substantial equivalence based on bench testing including ASTM D3578-05 (2010) for physical properties/dimensions, ASTM D5151-99 (2006) for pinholes, ASTM D6124-06 for powder residue, ASTM D5712-10 for protein content, and ISO 10993-10:2010 for dermal sensitization and primary skin irritation.

Technological Characteristics

Material: Latex. Standards: ASTM D3578-05 (2010) (dimensions, physical properties, protein content), ASTM D5151-99 (2006) (pinholes), ASTM D6124-06 (powder residue), ASTM D5712-10 (protein content). Biocompatibility: ISO 10993-10:2010 (dermal sensitization, primary skin irritation). Protein content: ≤50 µg/dm² water extractable protein.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand 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.

Predicate Devices

• Powder Free Polymer Coated Latex Examination Glove, Non-Sterile, With Protein Labeling Claim of 50 Micrograms per dm- of glove or Less of Water Soluble Protein (K092492)

Submission Summary (Full Text)

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# TOP CALIBRE SDN. BHD.

# JAN 1 8 2012

:

:

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

### Date: 02 September 2011

#### 1.0 Submitter:

Top Calibre Sdn Bhd 1-1, 2, Jalan Setia Prima U13/S Setia Alam, Seksyen U13, 40170 Shah Alam, Selangor, Malaysia

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

#### 2.0 Contact Person:

| Contact: | Ms Tracy Ngui | |
|------------------------|----------------|--|
| Telephone No.: | [phone] | |
| Fax No.:[phone] | | |

#### 3.0 . Name of Device:

Trade Name: Powder Free Latex Patient Examination Glove with Protein Content Labeling Claim (Contains 50 Micrograms per dm- of glove or Less of Water Extractable Protein)

Patient Examination Glove Common Name: Classification Name: Patient Examination Glove

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

Powder Free Latex Patient Examination Glove with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein), Class I patient examination gloves, Latex - 80L YY, meets all of the requirements of ASTM D3578-05 (2010) Standard Specification for Rubber Examination Glove.

Predicate Device: K092492, Powder Free Polymer Coated Latex Examination Glove, Non-Sterile, With Protein Labeling Claim of 50 Micrograms per dm- of glove or Less of Water Soluble Protein.

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# TOP CALIBRE SDN. BHD.

#### 5.0 Description of Device:

Powder Free Latex Patient Examination Glove with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) meets all the current specification for ASTM D3578-05 (2010).

#### 6.0 Intended Use of the Device:

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

#### Summary of the Technological Characteristics of the Device: 7.0 .

Powder Free Latex Patient Examination Glove with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) possesses the following technological characteristic (as compared to ASTM or equivalent standards):

| Characteristic | Standards | Device Performance |
|------------------------|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Dimensions | ASTM D 3578-05<br>(2010) | Meets |
| Physical Properties | ASTM D 3578-05<br>(2010) | Meets |
| Freedom from pin-holes | ASTM D 5151-99<br>(2006)<br>ASTM D 3578-05<br>(2010) | Meets |
| Powder Free Residue | ASTM D 6124-06<br>ASTM D 3578-05<br>(2010) | Meets |
| Protein Content | ASTM D 5712-10<br>ASTM D 3578-05<br>(2010) | Meets |
| Biocompatibility | Dermal Sensitization<br>(as ISO 10993-10:2010)<br><br>Primary Skin<br>Irritation Test<br>(as ISO 10993-10:2010) | Not a contact skin sensitizer<br><br>Not a primary skin irritant |

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## TOP CALIBRE SDN. BHD.

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

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 is not needed for market cleared examination gloves.

#### 10.0 Conclusion

It can be concluded that the Powder Free Latex Patient Examination Glove with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein), is safe and effective for use with chemotherapeutic agents and will perform according to the glove performance standards referenced in Section 7.0 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.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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

JAN 1 8 2012

Ms. Tracy Ngui QA Manager Top Calibre Sdn Bhd 1-1, 2, Jalan Setia Prima U13/S Setia Alam, Seksyen U13, Shah Alam, Selangor MALAYSIA 40170

Re: K112612

Trade/Device Name: Powder Free Latex Examination Glove With Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein)

Regulation Number: 21 CFR 880.6250

Regulation Name: Patient Examination Glove

Regulatory Class: I

Product Code: LYY

Dated: December 21, 2011

Received: December 27, 2011

Dear Ms. Ngui:

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 - Ms. Ngui

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 yours,

Anthony D. awat

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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# Indications for Use

### 510(k) Number (if known):

Powder Free Latex Patient Examination Glove With Protein Content Labeling Claim Device Name: (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein)

### Indications for Use:

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

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 IF NEEDED)

Concurrence of CDRH, Office Of Device Evaluation (ODE)

Elishth F. Clamin-William

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

510(k) Number: KI

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