POWDER-FREE VINYL EXAMINATION GLOVES

K071022 · Glormed Colombia S.A. · LYZ · Jul 5, 2007 · General Hospital

Device Facts

• Record ID: K071022
• Device Name: POWDER-FREE VINYL EXAMINATION GLOVES
• Applicant: Glormed Colombia S.A.
• Product Code: LYZ · General Hospital
• Decision Date: Jul 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

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

Device Story

Vinyl patient examination glove; powder-free; worn by healthcare examiners to provide barrier protection against infectious materials; prevents cross-contamination between patient and examiner. Device manufactured from vinyl; meets ASTM D5250-00 standards for physical properties, dimensions, and freedom from pinholes. Used in clinical settings; non-sterile; disposable.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing, including physical property testing (tensile strength, elongation), water leak testing (AQL 2.5), and biocompatibility testing (cytotoxicity, skin irritation, sensitization) per ISO 10993 standards.

Technological Characteristics

Material: Poly(vinyl chloride) (vinyl). Standards: ASTM D5250-00 (dimensions, physical properties), ASTM D5151-99 (pinholes), ASTM D6124-00 (powder-free). Biocompatibility: ISO 10993 (cytotoxicity, irritation, sensitization). Physical specs: Width 85-115mm, length 250mm, thickness 0.05-0.1mm. Tensile strength: 9 MPa (before/after aging). Ultimate elongation: 300% min. Water leak: AQL 2.5.

Indications for Use

Indicated for use as a patient examination glove worn on the examiner's hand to prevent cross-contamination between patient and examiner by providing a barrier against potentially infectious materials.

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

• Glormed International's vinyl powder-free glove (K983494)

Submission Summary (Full Text)

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Premarket Notification 510(k) K071022

Powder-Free Vinyl Examination Glove

## 21.0 Summary

- [1] 510(k) Summary of Safety and Effectiveness Information
- (2) Submitter: Glormed Colombia S.A. Mamonal Km. 9 Zona Franca La Candelaria, Manzana L Cartagena, Colombia Telephone: [phone] Fax: [phone]
- Contact: Sam Kao Telephone No. [phone] FAX No. [phone] E-mail: sam(@)kalmedsupply.com

June 14, 2007 Date:

- Trade name: (31 (Multiple private labels) Common name: Powder-Free Examination Glove, Vinyl Classification name: Patient examination gloves, powder-free (per proposed 21 CFR §880.6251)
- The predicate device is a Class I, powder-free vinyl exam glove 80LYZ that meets [4] all of the requirements of ASTM D 5250-00, "Standard Specification for Poly(vinvl chloride) Gloves for Medical Application."
- [5] The powder-free vinyl exam glove meets the current specifications of ASTM D 5250-00, "Standard Specification for Poly(vinyl chloride) Gloves for Medical Application. "
- A patient examination glove is a medical device intended for medical purposes that (61 is worn on the examiner's hand to prevent contamination between patient and examiner against potentially infectious materials.
- [7] Applicant's device comparison with FDA required technological characteristics:

| Characteristics | Standard |
|-----------------------|-----------------------------------------|
| Dimensions | Meets ASTM D 5250-00 |
| Physical Properties | Meets ASTM D 5250-00 |
| Freedom from pinholes | Meets ASTM D 5250-00 and ASTM D 5151-99 |
| Powder Free | Meets ASTM D 6124-00 and ASTM D 5250-00 |

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Premarket Notification 510(k) K071022

Powder-Free Vinyl Examination Glove

| Biocompatibilty: (based on ISO 10993) | |
|---------------------------------------|--------|
| Cytotoxicity - Agar Diffusion | Passed |
| Primary Skin Irritation | Passed |
| Guinea Pig Sensitization | Passed |

## Measured Parameter of Applicant Device Compared to Standard:

| ASTM D5250 / ASTM D 6124 Requirement | Applicant Device Specification |
|--------------------------------------|-----------------------------------------|
| Width (mm) | |
| Small | 85 +/- 5 |
| Medium | 95 +/- 5 |
| Large | 105 +/- 5 |
| X-Large | 115 +/- 5 |
| Length (mm) – all sizes | 250 +/- 10 |
| Thickness (mm) -- all sizes | |
| Finger | 0.05 minimum |
| Palm | 0.1 minimum |
| Physical Testing | |
| Tensile Strength | |
| (in MPa) | Before Aging 9 min<br>After Aging 9 min |
| Ultimate Elongation | |
| (in %) | 300% min |
| Water Leak Test | AQL 2.5, Level I |

Both its intended use and physical characteristics is equivalent to legally marketed vinyl powder-free examination gloves. It is substantially equivalent to gloves approved as Glormed International's vinyl powder-free glove K983494.

- The performance test data that support a determination of substantial equivalence [8] are described above in Section 7.
- 191 Clinical data are not needed for examination gloves.
- [10] (Multiple private labels) Powder-Free Vinyl Examination Glove is safe and effective and will perform according to glove performance standards referenced in Section 7 above, thereby meeting ASTM D5250 and D6124 standards, FDA requirements, pinhole AQL requirement, and labeling claims for the product. Consequently, this patient examination glove is substantially equivalent to currently marketed patient examination gloves.
- [11] This summary will include any additional safety and effectiveness information reasonably deemed necessary by FDA.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle symbol, with three wing-like shapes stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 5 2007

Glormed Colombia S.A. C/O Mr. Sam Kao Project Manager KalMed Supply 2700 North Main Street Suite 506 Santa Ana, California 92705

Re: K071022

Trade/Device Name: Vinyl Patient Examination Glove, Powder-Free Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: June 14, 2007 Received: June 15, 2007

Dear Mr. Kao:

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.

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.

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Page 2 -- Mr. Kao

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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), please contact the Office of 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 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,

Suste Y. Michie and
Chris Lins, Ph.D.

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

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## Indications for Use

510(k) Number (if known): K071022

Device Name: Vinyl Patient Examination Glove, Powder-Free

Indications For Use:

Based upon 21 CFR §880.6251 "Patient examination glove, powder-free"

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

Over-The-Counter Use Prescription Use AND/OR (Part 21 CFR 801 Subpart D) (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)

Shule M. Muephy, 42

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

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510(k) Number: K070227