BLUE LATEX EXAM GLOVES NON STERILE CHLORINATED POWDER FREE

K073299 · Betel Care Sdn. Bhd. · LYY · Mar 5, 2008 · General Hospital

Device Facts

• Record ID: K073299
• Device Name: BLUE LATEX EXAM GLOVES NON STERILE CHLORINATED POWDER FREE
• Applicant: Betel Care Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Mar 5, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A medical gloves is worn on the hand of healthcare and or similar personnel to prevent contamination between healthcare personnel and the patient. A patient examination gloves is a disposable device intended for medical purposes worm on the examiner, s hand to prevent contamination between patient and examiner. This gloves is intended for medical and dental use.

Device Story

Disposable, non-sterile, blue, powder-free natural rubber latex examination gloves. Worn by healthcare and dental personnel to provide a protective barrier against cross-contamination between examiner and patient. Manufactured via standard latex dipping processes. Performance verified against ASTM standards for water leak, residue, tensile strength, elongation, and extractable protein. Used in clinical and dental settings. Provides physical barrier protection; does not claim hypoallergenic properties. Contains natural rubber latex, posing potential allergic reaction risk to sensitive individuals.

Clinical Evidence

Bench testing only. Device performance verified against ASTM standards: ASTM D5151-06 (water leak), ASTM D6124-06 (residue), ASTM D3578-05 (tensile strength/elongation), and ASTM D5712-05e1 (extractable protein). Biocompatibility testing included primary skin irritation and dermal sensitization studies, both of which passed.

Technological Characteristics

Material: Natural rubber latex. Form factor: Powder-free, blue, non-sterile examination glove. Standards: ASTM D3578-05 (physical properties), ASTM D5151-06 (water leak), ASTM D6124-06 (residue), ASTM D5712-05e1 (extractable protein).

Indications for Use

Indicated for use by healthcare and dental personnel as a disposable barrier on the examiner's hand to prevent cross-contamination between the examiner and the patient. Contains natural rubber latex; not for use by latex-sensitized individuals.

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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Image /page/0/Picture/0 description: The image shows a logo with the letters "RELE" arranged around a stylized image of three plants. Below the letters and plants, there is a rectangular box with the words "natural rubber product" written inside. The logo has a vintage or retro appearance due to its black and white color scheme and simple design. The text is small and somewhat difficult to read, but the overall design is clear and recognizable.

lcare Son

Image /page/0/Picture/2 description: The image shows two logos. The logo on the left is a circular logo with the letters "BSI" at the top and the word "REGISTERED" around the bottom. The logo on the right is a square logo with a crown at the top and the words "UKAS QUALITY MANAGEMENT" in the middle. The number "003" is at the bottom of the logo.

Lot 3342, Jalan Keretapi Lama, 7½ Mile, Off Jalan Kapar, 42200 Kapar, Selangor Darul Ehsan, West Malaysia.

Tel: [phone] Fax: [phone]

510K Summary for BETELCARE SDN BHD-Latex Exam gloves Blue [e-mail]

- 1. Submission Applicant:
K073299

Name: Betelcare Sdn Bhd Address : Lot 3342,Jalan Keretapi Lama 7.5 Miles Off Jalan Kapar,Kapar Selangor Darul Ehsan West Malaysia Telephone No: 603 3290 3301 Fax No: 603 3290 3303 Email address : [e-mail] Contact Person: K.B .Siah

Registration Form 2891 number: 8040910 Device Listing Number : A 653345 Activity : Manufacturer

Applicant 510k number: K893166,C047750

- 2. Device Particulars: Device Name : Powder Free Latex Exam gloves Blue Common Name : Chlorinated Blue Powder Free Latex Exam Gloves Classification: Patient Examination Gloves
- 3. Device Classification Device Class: Class II Product code: LYY
- 4. Device Classification Device Class: Class II Product code: LYY
- 5. Summary of Intended Use A medical gloves is worn on the hand of healthcare and or similar personnel to prevent contamination between healthcare personnel and the patient.

MAR - 5 2008

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Image /page/1/Picture/0 description: The image shows a logo with the letters "REEL" arranged vertically on the left and right sides of a semi-circular arch. Inside the arch, there are three stylized plants with leaves. Below the arch, there is a rectangular box with the words "natural rubber product" written in a smaller font. The logo appears to be for a company that produces natural rubber products.

are Sdn

Image /page/1/Picture/2 description: The image contains two logos. The logo on the left is the BSI Registered logo, which features a heart shape inside a circle with the letters BSI at the top. The logo on the right is the UKAS Quality Management logo, which features a crown above a checkmark with the words UKAS Quality Management below it. The number 003 is printed below the UKAS logo.

Lot 3342, Jalan Keretapi Lama, 71/2 Mile, Off Jalan Kapar, 42200 Kapar, Selangor Darul Ehsar, West Malaysia.

Tel: [phone]. (603) 3290 3302 Fax: [phone] Email: betellapd jaring my www.betel.com.my

- 6. Comparison Characteristic:
Characteristic Reference Doc Betel Device performance Meets or Exceeds Water Leak ASTM D 5151-06 ASTM D6124-06 Meets or Exceeds Residue Powder Unaged ASTM D 3578-05 Meets or Exceeds Tensile :- Aged Meets or Exceeds ASTM D 3578 -05 Unaged ASTM D 3578-05 Meets or Exceeds Elongation@break ASTM D 3578-05 Meets or Exceeds Unaqed Meets or Exceeds Aged ASTM D 3578 -05

Extractable Protein Test ASTM D 5712-05e1 Meets or Excceds

The above device does NOT include "hypoallergenic"labelling in packing.

- 7. Labeling and Attributes
Safe use of this gloves by or on latex sensitized individuals has not been established.This product contains natural rubber latex which may cause allergic reactions in some individual.

- 8. Assesment of Non clinical Performance Data The device meets or exceeds the ASTM Std or Equivalent Standards and FDA pin hole requirements
- 9. Assesment of Biocompatibility

Primary Skin Irritant Test: Pass Dermal Sensitization Study: Pass

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Image /page/2/Picture/0 description: The image is a logo with the letters "R", "E", "L", and "E" arranged around a central design. The central design features three plant-like figures. Below the letters is a rectangular box containing the words "natural rubber product" in a stylized font. The logo appears to be for a company or organization related to natural rubber products.

care Sdn

Image /page/2/Picture/2 description: The image contains two logos. The logo on the left is a circular seal with the word "REGISTERED" around the bottom half of the circle and "QSI" at the top. Inside the circle is a heart shape pointing downwards. The logo on the right is a square with a crown on top of a check mark. Below the check mark is the text "UKAS QUALITY MANAGEMENT" and the number "003".

Lot 3342, Jalan Keretapi Lama, 71/2 Mile, Off Jalan Kapar, 42200 Kapar, Selangor Darul Ehsan, West Malaysia.

Tel: [phone] Fax: [phone] Email betellapd jaring my www.betel.com.my

- 10. Conclusion of non clinical and biocompability performance The device has been carefully compared to legally marketed devices in the 510K. The data summaries indicates that the proposed device meets or exceeds all acceptable requirements for Powder Free Latex Exam gloves blue non sterile
I,Keng Beng Siah,the Chief Executive Officer of BETELCARE SDN BHD,certify That to the best of my knowledge and belief and based on the data and Information submitted to me in the course of my responsibilities as CEO of Betelcare Sdn Bhd and in reliance thereupon the data and information Submitted in the pre market notification are truthful and accurate no facts Materials to a review of the substantial equivalence of the device have been Knowingly omitted from this submission.

Image /page/2/Picture/8 description: The image shows a signature. The signature is illegible and appears to be a series of overlapping lines and curves. The word "Signature" is written above the signature.

KENG BENG SIAH Name

22nd Feb 2008 Date

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Keng Beng Siah Director Betelcare Sdn Bhd Lot 3342 Jalan Keretapi Lama 7 1/2 Mile, Off Jalan Kapar, 42200 Kapar Selangor Darul Ehsan, WEST MALAYSIA

Re: K073299

Trade/Device Name: Betel Latex Exam Gloves, Blue, Powder Free, Non Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: February 22, 2008 Received: February 27, 2008

MAR - 5 2008

Dear Mr. Siah:

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. Siah

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 (OS) 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,

Snyte Y. M. Michie MD.

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): 510K number is K073299

Betel Hatex Exam Gloves,Blue ,Powder Free,Non sterile Device Name: Indications For Use:

> A patient examination gloves is a disposable device intended for medical purposes worm on the examiner, s hand to prevent contamination between patient and examiner.

This gloves is intended for medical and dental use.

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)

Stile H. Murphy ho
Division Sign Off

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

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510(k) Number: K073999