(34 days)
The Powder Free Latex Examination Gloves, Sterile 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.
The Powder Free Latex Examination Gloves, Sterile with Protein Content Labeling Claim is equivalent to the existing model, i.e. Comfit Sterile Latex Examination Gloves (Powder Free) which had submitted and cleared under 510(k) number K944141. The difference in this submission is: - To include Protein Content Labeling Claim statements on label, i.e. a) "This latex glove contains 50 micrograms or less of total water extractable protein per gram" and "Safe use of this glove by or on latex sensitised individuals has not been established". The device remains no change in product design and the additional claim does not affect the intended use of the device as well as it does not affect its safety and effectiveness. The indication for use and proposed labeling for the device are illustrated in subsequent sections. The Powder Free Latex Examination Gloves, Sterile with Protein Content Labeling Claim meets all the requirements of ASTM standard D 3578 - 01a22 and FDA 21 CFR 800.20.
This 510(k) summary describes a Powder Free Latex Examination Glove, Sterile with Protein Content Labeling Claim. The submission seeks to include protein content labeling claims on the existing device, which was previously cleared under 510(k) K944141. The core device design and intended use remain unchanged.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Standard | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 3578 - 01aE2 | Meets |
| Physical Properties | ASTM D 3578 - 01aE2 | Meets |
| Freedom from pinholes | ASTM D 3578 - 01aE2 & FDA 21 CFR 800.20 | Meets |
| Powder Residual | ASTM D 6124 - 01 | Meets (< 2 mg/glove) |
| Protein Level | ASTM D 5712-95 | < 50 µg/g |
2. Sample size used for the test set and the data provenance
The document indicates that the device "meets" the specified ASTM standards and FDA regulations, and provides specific values for Powder Residual and Protein Level. However, it does not explicitly state the sample size used for the tests to demonstrate compliance.
The provenance of the data is not specified (e.g., country of origin, retrospective/prospective). It is implied that the testing was conducted by or on behalf of WRP Asia Pacific Sdn Bhd.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a medical glove and its performance is evaluated against material and physical property standards, not through expert-driven clinical assessment or interpretation.
4. Adjudication method for the test set
Not applicable. The evaluation is based on objective measurements against established ASTM and FDA standards for material and physical properties, not subjective assessment requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a medical glove; it is not an AI-powered diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a medical glove, not an algorithm. The "standalone" performance here refers to the device's ability to meet physical and chemical standards independently. The reported performance is a standalone assessment of the glove's properties.
7. The type of ground truth used
The ground truth used is established by recognized ASTM (American Society for Testing and Materials) standards and FDA (Food and Drug Administration) regulations. These standards define the acceptable specifications and test methods for physical properties (dimensions, physical properties, freedom from pinholes), chemical properties (powder residual), and protein content in examination gloves.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-based device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of medical device.
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WRP WRP Asia Pacific Sdn Bhd
K030i57
FEB 1 9 2003
510(k) SUMMARY
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1.0 Submitter:
| Name: | WRP Asia Pacific Sdn Bhd |
|---|---|
| Address: | Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi,43900 Sepang, Selangor Darul Ehsan, MALAYSIA |
| Phone No.: | +60 3 8706 1486 |
| Fax No.: | +60 3 8706 1485 |
1 4 JAN 2003 Date of Summary Prepared:
2.0 Contact Person:
| Name: | Mr. Terence Lim |
|---|---|
| Phone No .: | +60 3 8706 1486 |
| Fax No.: | +60 3 8706 1485 |
3.0 Device Identification:
| Trade Name: | 1) Comfit, and2) Multiple or Customers' Trade Name |
|---|---|
| Device Name: | Powder Free Latex Examination Gloves, Sterile with ProteinContent Labeling Claim |
| Common Name: | Examination Gloves |
| Classification Name: | Patient Examination Gloves (per 21 CFR 880.6250) |
4.0 Identification of the Legally Marketed Device:
Class I patient examination gloves, 80LYY, powder free, that meets all the
requirements of ASTM standard D 3578 – 01a52 and FDA 21 CFR 800.20.
5.0 Description of the Device:
The Powder Free Latex Examination Gloves, Sterile with Protein Content Labeling Claim is equivalent to the existing model, i.e. Comfit Sterile Latex Examination Gloves (Powder Free) which had submitted and cleared under 510(k) number K944141.
Page 1 of 3
Vour Partner In Protection
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Image /page/1/Picture/0 description: The image shows the logo for WRP Asia Pacific Sdn Bhd. The logo consists of the letters "WRP" in white inside of a black oval. To the right of the logo is the company name in black text. Below the company name is the number sequence "1 4 7 8 1 7 V".
The difference in this submission is:
- To include Protein Content Labeling Claim statements on label, i.e. a) "This latex glove contains 50 micrograms or less of total water extractable protein per gram" and "Safe use of this glove by or on latex sensitised individuals has not been
established".
The device remains no change in product design and the additional claim does not affect the intended use of the device as well as it does not affect its safety and effectiveness. The indication for use and proposed labeling for the device are illustrated in subsequent sections.
The Powder Free Latex Examination Gloves, Sterile with Protein Content Labeling Claim meets all the requirements of ASTM standard D 3578 - 01a22 and FDA 21 CFR 800.20.
6.0 Intended Use of the Device:
The Powder Free Latex Examination Gloves, Sterile with Protein Content Labeling Claim 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.
7.0 Summary of Technological Characteristics for the Modified Device:
The Powder Free Latex Examination Gloves, Sterile with Protein Content Labeling Claim are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|---|---|---|
| Dimensions | ASTM D 3578 - 01aE2 | Meets |
| Physical Properties | ASTM D 3578 - 01aE2 | Meets |
| Freedom from pinholes | ASTM D 3578 - 01aE2FDA 21 CFR 800.20 | Meets |
| Powder Residual | ASTM D 6124 - 01 | Meets< 2 mg/glove |
| Protein Level | ASTM D 5712-95 | < 50 µg/g |
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Image /page/2/Picture/0 description: The image shows the logo for WRP Asia Pacific Sdn Bhd. The logo consists of the letters "WRP" in white inside of a black oval. To the right of the logo is the company name in black text. Below the company name is the number 147817V.
8.0 Conclusion:
The Powder Free Latex Examination Gloves, Sterile with Protein Content Labeling Claim will perform according to the glove performance standards referenced in section 7 above and meet ASTM standards, and FDA requirements for waterleak test on pinhole AQL. Consequently, this device is substantially equivalent to currently marketed devices.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 9 2003
Mr. Terence Lim Associate Manager, RA/QA WRP Asia Pacific Sdn. Bhd. Lot 1. Jalan 3. Kawasan Perushaan, Bandar Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA
Re: K030157
Trade/Device Name: Powder Free Latex Examination Gloves, Sterile with Protein Content Labeling Claim (50 Micrograms or Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: January 14, 2003 Received: January 16, 2003
Dear Mr. Lim:
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. Lim
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 vour 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 (301) 594-4618. 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/dsma/dsmamain.html
Sincerely vours.
Susan Dunne
Susan Runner, DDS, MA Interim 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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WRP Asia Pacific Sdn Bhd
1 4 7 8 1 7 V
INDICATIONS FOR USE
Applicant:
510(k) Number (if known):
Device Name:
WRP Asia Pacific Sdn Bhd
FREE POWDER EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM ( 50 MICROGRAM ORLESS
Indications For Use:
The Powder Free Latex Examination Gloves, Sterile 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.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter
(301.105)
OR Over-The-Counter
St.B. for Clin
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
Page I of I
510(k) Number 110-3015
Your Partner In Protection
§ 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.