LATEX EXAMINATION GLOVES (POWDERED)

K120693 · Top Calibre Sdn Bhd · LYY · May 8, 2012 · General Hospital

Device Facts

• Record ID: K120693
• Device Name: LATEX EXAMINATION GLOVES (POWDERED)
• Applicant: Top Calibre Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: May 8, 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 powdered natural rubber latex patient examination glove; ambidextrous; worn by healthcare personnel during patient examinations to provide a barrier against contamination. Device is non-sterile and intended for single use. Performance characteristics meet ASTM D3578-05 (2010) standards for dimensions, physical properties, powder content, and protein content. Protein content is labeled as 200 micrograms per dm2 or less of water-extractable protein. Biocompatibility testing confirms the material is not a primary skin irritant or contact skin sensitizer.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing including dimensions, physical properties, freedom from pin-holes (ASTM D5151-99), powder amount (ASTM D6124-06), protein content (ASTM D5712-10), and biocompatibility (ISO 10993-10).

Technological Characteristics

Material: Natural rubber latex. Form factor: Ambidextrous, powdered. Standards: ASTM D3578-05 (2010), ASTM D5151-99 (2006), ASTM D6124-06, ASTM D5712-10. Biocompatibility: ISO 10993-10 (Primary Skin Irritation, Dermal Sensitization). Protein content: ≤ 200 µg/dm2.

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. Suitable for general patient examination settings.

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

• Powdered Latex Patient Examination Glove, With Protein Content Labeling Claim (K003737)

Submission Summary (Full Text)

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# K120093

# TOP CALIBRE SDN. BHD.

- WAY. -- 8 2012

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

## Date: 11 April 2012

1.0 Submitter:

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

Telephone No .: 4603 3291 0516 [phone] Fax No.:

### 2.0 Contact Person:

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

#### Name of Device: 3.0

Trade Name: Powdered Latex Patient Examination Glove with Protein Content Labeling Claim (Contains 200 Micrograms per dm- of glove or Less of Water Extractable Protein) Patient Examination Glove Common Name:

Classification Name: Patient Examination Glove

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

Powdered Latex Patient Examination Glove with Protein Content Labeling Claim (Contains 200 Micrograms per dm2 of glove or Less of Water Extractable Protein), Class I patient examination gloves, Latex - 80LYY, meets all of the requirements of ASTM D3578-05 (2010) Standard Specification for Rubber Examination Glove.

Predicate Device: K003737, Powdered Latex Patient Examination Glove, With Protein Content Labeling Claim (Contains 200 Micrograms per dm2 of glove or Less of Water Extractable Protein)

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# TOP CALIBRE SDN. BHD.

### Description of Device: 5.0

Powdered Latex Patient Examination Glove with Protein Content Labeling Claim (Contains 200 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

Powdered Latex Patient Examination Glove with Protein Content Labeling Claim (Contains 200 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) | Meets |
| | ASTM D 3578-05<br>(2010) | |
| Powder Amount | ASTM D 6124-06 | Meets |
| | ASTM D 3578-05<br>(2010) | |
| Protein Content | ASTM D 5712-10 | Meets |
| | ASTM D 3578-05<br>(2010) | |
| Biocompatibility | Dermal Sensitization<br>(as ISO 10993-<br>10:2010) | Not a contact skin sensitizer |
| | Primary Skin<br>Irritation Test<br>(as ISO 10993-<br>10:2010) | 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 Powdered Latex Patient Examination Glove with Protein Content Labeling Claim (Contains 200 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.

The device comparison below outlines the similarity, and/or differences between the proposed device and the predicate device for the substantial equivalent determination.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| Characteristics | Predicate Device | Proposed Device |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | K003737, Powdered Latex<br>Patient Examination Glove with<br>Protein Content Labeling Claim<br>(200 Micrograms per gram of<br>glove less) | Powdered Latex Patient<br>Examination Glove, with Protein<br>Content Labeling Claim<br>(Contains 200 Micrograms per<br>dm² of glove or less of Water<br>Extractable Protein) |
| Device Description/<br>Regulation Number | Patient Examination Glove/<br>21 CFR Part 880.6250 | Identical |
| Product Code | 80 LYY | Identical |
| Intended Use | Intended for medical purposes<br>that is worn on the examiner's<br>hand to prevent contamination<br>between patient and examiner. | Identical |
| Indications for Use | A patient examination glove is a<br>disposable device intended for<br>medical purposes that is worn<br>on the examiner's hand to<br>prevent contamination between<br>patient and examiner. | Identical |
| | | |
| Characteristics | Predicate Device | Proposed Device |
| | Powdered<br>Latex<br>K003737, | Powdered Latex Patient |
| | Patient Examination Glove with | Examination Glove, with Protein |
| | Protein Content Labeling Claim | Content Labeling Claim |
| | (200 Micrograms per gram of | (Contains 200 Micrograms per |
| | glove less) | dm2 of glove or less of Water |
| | | Extractable Protein) |
| Design | Ambidextrous, in different sizes<br>per ASTM D3578 dimension<br>requirement | Identical |
| Materials | Natural Rubber Latex | Identical |
| Color | Natural Color | Identical |
| Performance | Not Applicable (Non-Sterile) | Identical |
| Sterility<br>I.<br>Freedom from<br>II. | Meets ASTM D3578 | Identical |
| holes | | |
| Dimension<br>III. | Meets ASTM D3578 | Identical |
| Physical<br>IV.<br>Properties | Meets ASTM D3578 | Identical |
| V.<br>Powder<br>Amount | Meets ASTM D3578 | Identical |
| VI-<br>-Protein | Meets-ASTM-D3578 | Identical- |
| Content | | |
| Single Use | Yes | Identical |
| Biocompatibility | Passes | |
| Test | i. Primary Skin Irritation Test | Identical |
| | ii. Dermal Sensitization Test | Identical |
| Packaging | Packed in Dispenser Boxes | Identical |
| Labeling Claim | Extractable<br>Protein<br>With<br>Content Labeling Claim | Identical |

### Substantial Equivalence Comparison Table

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# TOP CALIBRE SDN. BHD.

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### Public Health Service

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

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

MAY - 8 2012

Re: K120693

Trade/Device Name: Powdered Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 200 Micrograms per dm2 of Glove or Less of Water Extractable Protein) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: April 11, 2012 Received: April 12, 2012

Dear Ms. Tracy 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 ucm 1 15809.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.html 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. Owens

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):

Powdered Latex Patient Examination Gloves with Protein Content labeling Claim Device Name: (Contains 200 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) X

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

Concurrence of CDRH, Office Of Device Evaluation (ODE)

Elizabetk. F-Clunie-Willen

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

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510(k) Number: K120693