KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50UG OR LESS)

K093375 · Koon Seng Sdn Bhd · LYY · Dec 2, 2009 · General Hospital

Device Facts

• Record ID: K093375
• Device Name: KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50UG OR LESS)
• Applicant: Koon Seng Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Dec 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended Use

A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner. These gloves are not intended to be used as a chemical barrier.

Device Story

Disposable powder-free polymer-coated latex examination glove. Used by clinicians and healthcare personnel to provide a physical barrier against contamination between patient and examiner. Device is worn on hands or fingers during medical examinations. Provides protection without the use of powder; features a protein content labeling claim of 50 micrograms or less. Does not function as a chemical barrier.

Clinical Evidence

Bench testing only. Device performance evaluated against ASTM D3578-05 standards. Testing included dermal sensitization, primary skin irritation, iodine testing, and tensile strength measurements. Results confirmed compliance with physical specifications and dimensions.

Technological Characteristics

Latex material; polymer coated; powder-free. Dimensions and physical properties (tensile strength, elongation) meet ASTM D3578-05 standards. Protein content labeled at 50 micrograms or less. Biocompatibility confirmed via skin irritation and dermal sensitization testing.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent cross-contamination between patient and examiner. Not intended for use as a chemical barrier.

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

• SGMP Company Ltd. Powder-free Latex Examination Gloves (K071060)
• Pt. Maja Agung Latexindo Powder-free Latex Examination Gloves (K081488)

Submission Summary (Full Text)

{0}------------------------------------------------

K093375

## EXHIBIT #1

# 510(k) Summary

DEC - 2 2009

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

# 1. Applicant:

Koon Seng Sdn. Bhd. Ptd 16058. Kawasan Perindustrian Tangkak, Jalan Muar, 84900 Tangkak, Johor, Malaysia

# 2. Manufacturer:

Koon Seng Sdn. Bhd. Ptd 16058, Kawasan Perindustrian Tangkak, Jalan Muar, 84900 Tangkak, Johor, Malaysia

# 3. Submitter:

Mr. Jigar Shah Official Correspondent for Koon Seng Sdn. Bhd. Summary Prepared on: April 7, 2009

### 4. Address:

mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021 Tel: [phone] Fax: [phone] [e-mail]

#### 5. Trade/proprietary Name:

'KS-CARE' Powder Free Polymer Coated Latex Examination Glove with Protein Content labeling Claim (50 Micrograms or Less).

# 6. Common Names: POWDER-FREE Patient Examination Glove

- 7. Classification name: Patient Examination Glove
- 8. Classification number: 21 CFR 880.6250

1

{1}------------------------------------------------

# 9. Device Description:

Powder free Latex Examination Glove is a class I device having product code LYY. It is a disposable device that meets all requirements of ASTM D3578-05.

# 10. Intended Use:

A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner. These gloves are not intended to be used as a chemical barrier.

# 11. Substantial Equivalence Discussion:

A powder free patient examination glove is substantially equivalent to the predicate devices.

| Characteristic<br>and<br>parameters | 'KS-CARE'<br>Powder Free<br>Polymer Coated<br>Latex<br>Examination<br>Glove with<br>Protein Content<br>labeling Claim<br>(50 Micrograms<br>or Less) | SGMP Company<br>Ltd. Powder-free<br>Latex<br>Examination<br>Gloves<br>510K # K071060 | Pt. Maja Agung<br>Latexindo<br>Powder-free<br>Latex<br>Examination<br>Gloves<br>510K # K081488 | Substantial<br>Equivalence<br>(SE) |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Product Code | LYY | LYY | LYY | |
| Intended Use | A powder free<br>patient<br>examination<br>glove is a<br>disposable device<br>intended for<br>medical purposes<br>that is worn on<br>the examiners<br>hand or finger to<br>prevent<br>contamination<br>between patient<br>and examiner. | A powder free<br>patient examination<br>glove is a<br>disposable device<br>intended for<br>medical purposes<br>that is worn on the<br>examiners hand or<br>finger to prevent<br>contamination<br>between patient and<br>examiner. | A powder free<br>patient<br>examination glove<br>is a disposable<br>device intended for<br>medical purposes<br>that is worn on the<br>examiners hand or<br>finger to prevent<br>contamination<br>between patient<br>and examiner. | SE |
| Width (size<br>medium) | 95 +/- 5 mm | 90-97mm | 95 +/- 5 mm | SE |
| Overall length | Min 240 mm | 241 mm | 240 mm | SE |
| Palm thickness | Min 0.08 mm | 0.10 mm | 0.10 mm | |

{2}------------------------------------------------

| Finger thickness | Min 0.08 mm | 0.13 mm | 0.10 mm | |
|-------------------------------------|--------------------------|-----------------------------|---------|------------------|
| Tensile strength pre aging min | Min 18 Mpa | 27 mpa | 18 mpa | |
| Tensile strength after aging min | Min 14 Mpa | 25.8 | 14 mpa | Minor difference |
| Ultimate elongation pre aging min | Min 650% | 830% | 650% | |
| Ultimate elongation after aging min | Min 500% | 730% | 500% | |
| Meets Biocompatibility | YES | Yes | Yes | SE |
| Duration of bio-compatibility | Except product change | | | |
| Skin irritation test | Pass | Pass | Pass | SE |
| Dermal sensitization | Pass | Pass | Pass | |
| AQL | 1.5% | 2.5% | NA | SE |
| Residual Powder Content | Max 2.0mg/glove | 1.1 mg/glove | NA | SE |
| Residual Protein Level | < 50 $ μ $ g/g | < 50 $ μ $ g/ dm2 | NA | SE |

### 12. Summary of Testing:

| Test | Results |
|------------------------------|----------------------------------------------------|
| a. Dermal Sensitization Test | Passes |
| b. Primary Skin irritation | Passes |
| c. Iodine Test | Passes |
| d. Tensile strength | Gloves meets the requirements of<br>ASTM D3578-05. |

The standards used by Koon Seng Sdn. Bhd. to determine substantial equivalence is based on ASTM D3578-05a. All testing meets requirements for physical specifications and dimensions conducted on gloves, Inspection level S-2, AQL 4.0, pinholes at AQL 2.5

We do not claim our gloves to be hypoallergenic.

### 13. Conclusion:

'KS-CARE' Powder Free Polymer Coated Latex Examination Glove (with Protein Content labeling) performance was equivalent to any other conventional method evaluated. Our evaluation concluded that our device raises no new issues of Safety and effectiveness.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle's head in profile, with three swooping lines representing the feathers. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

# DEC - 2 2009

Koon Seng Sdn. Bhd. C/O Mr. Jay Y. Kogoma Responsible Third Party Official Intertek Testing Services NA, Incorporated 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

Re: K093375

Trade/Device Name: Powder Free Polymer Coated Latex Examination Glove with Protein Content Labeling Claim (50 Micrograms or Less) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: November 17, 2009 Received: November 18, 2009

Dear Mr. Kogoma:

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 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.

{4}------------------------------------------------

#### Page 2- Mr. Kogoma

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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours.

Anthony D. Austin Jr.

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

#### EXHIBIT #3

#### Indications for Use

510(k) Number (if known): K_09 3375

Applicant: Koon Seng Sdn. Bhd.

Device Name: Powder Free Polymer Coated Latex Examination Glove with Protein Content Labeling Claim (50 Micrograms or Less)

### Indications for Usc:

A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth F. Qawaine-Willien Z

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

0 93375 510(k) Number: