(103 days)
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.
Powder Free Latex Exam gloves Blue
This document is a 510(k) Summary for Betelcare Sdn Bhd's Latex Exam Gloves, Blue, Powder Free, Non Sterile. It describes the device's characteristics and how it meets acceptance criteria, primarily through comparison to established ASTM standards.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Reference Document | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Water Leak | ASTM D 5151-06 | Meets or Exceeds ASTM D5151-06 Standard | Meets or Exceeds |
| Residue Powder | ASTM D 6124-06 | Meets or Exceeds ASTM D6124-06 Standard | Meets or Exceeds |
| Tensile (Unaged) | ASTM D 3578-05 | Meets or Exceeds ASTM D3578-05 Standard | Meets or Exceeds |
| Tensile (Aged) | ASTM D 3578-05 | Meets or Exceeds ASTM D3578-05 Standard | Meets or Exceeds |
| Elongation @ break (Unaged) | ASTM D 3578-05 | Meets or Exceeds ASTM D3578-05 Standard | Meets or Exceeds |
| Elongation @ break (Aged) | ASTM D 3578-05 | Meets or Exceeds ASTM D3578-05 Standard | Meets or Exceeds |
| Extractable Protein Test | ASTM D 5712-05e1 | Meets or Exceeds ASTM D5712-05e1 Standard | Meets or Exceeds |
| Biocompatibility (Primary Skin Irritation) | (Not explicitly stated, but standard test) | Pass | Pass |
| Biocompatibility (Dermal Sensitization) | (Not explicitly stated, but standard test) | Pass | Pass |
| Pin Hole Requirements | FDA (specific standard not explicitly listed) | Meets FDA pin hole requirements | Meets or Exceeds |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for testing each characteristic. It simply states that the "device meets or exceeds the ASTM Std or Equivalent Standards and FDA pin hole requirements" and provides "Assesment of Non clinical Performance Data" and "Assesment of Biocompatibility."
The data provenance is Malaysia (West Malaysia, specifically Kapar, Selangor Darul Ehsan), as the applicant Betelcare Sdn Bhd is located there and conducts the testing. The data appears to be prospective as it is submitted for premarket notification of a new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The testing relies on adherence to established ASTM standards and FDA requirements, which implies a standardized test procedure rather than expert consensus on individual cases for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable in the context of this type of device testing. The assessment is based on a device meeting pre-defined quantitative and qualitative standards (ASTM, FDA) rather than human adjudication of performance on a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. This document describes the performance of a medical device (exam gloves) against established industry standards. MRMC studies are typically performed for diagnostic or AI-driven systems where human interpretation is a critical component.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in essence. The testing described is a standalone assessment of the physical and biological properties of the examination gloves. There is no "human-in-the-loop" performance in the sense of a diagnostic algorithm assisted by a human. The product's performance (e.g., water leak, tensile strength) is evaluated directly against a standard.
7. The Type of Ground Truth Used
The ground truth used is primarily standardized quantitative measurements against established industry specifications (ASTM D 5151-06, ASTM D 6124-06, ASTM D 3578-05, ASTM D 5712-05e1) and regulatory requirements (FDA pin hole requirements, biocompatibility tests). These standards define acceptable levels of performance.
8. The Sample Size for the Training Set
This information is not applicable or provided. This is a medical device approval summary, not a machine learning model. There is no "training set" in the context of developing examination gloves. The manufacturer would have internal R&D and quality control processes to ensure the product consistently meets specifications, but these are not referred to as "training sets."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above.
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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: (603) 3290 3301, (603) 3290 3302 Fax: (603) 3290 3303
510K Summary for BETELCARE SDN BHD-Latex Exam gloves Blue PowleteriFreet@pd.jaring.my
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- Submission Applicant:
K073299
- Submission Applicant:
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 : kbsiah@betel.com.my Contact Person: K.B .Siah
Registration Form 2891 number: 8040910 Device Listing Number : A 653345 Activity : Manufacturer
Applicant 510k number: K893166,C047750
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- Device Particulars: Device Name : Powder Free Latex Exam gloves Blue Common Name : Chlorinated Blue Powder Free Latex Exam Gloves Classification: Patient Examination Gloves
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- Device Classification Device Class: Class II Product code: LYY
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- Device Classification Device Class: Class II Product code: LYY
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- 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: (603) 3290 3301. (603) 3290 3302 Fax: (603) 3290 3303 Email: betellapd jaring my www.betel.com.my
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- 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
- Comparison Characteristic:
Extractable Protein Test ASTM D 5712-05e1 Meets or Excceds
The above device does NOT include "hypoallergenic"labelling in packing.
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- 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.
- Labeling and Attributes
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- Assesment of Non clinical Performance Data The device meets or exceeds the ASTM Std or Equivalent Standards and FDA pin hole requirements
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- 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: (603) 3290 3301, (603) 3290 3302 Fax: (603) 3290 3303 Email betellapd jaring my www.betel.com.my
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- 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.
- 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
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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
§ 880.6250 Non-powdered patient examination glove.
(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.