(35 days)
The Powder Free Latex Examination Gloves with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less), Non 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 Glove with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less), Non Sterile meets all the requirements of ASTM Standard D 3578 - 00 and FDA 21 CFR 800.20.
The medical device in question is the "Powder Free Latex Examination Glove with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less), Non Sterile." The study described is a non-clinical performance evaluation comparing the device's characteristics against established standards.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 3578 - 00 | Meets |
| Physical Properties | ASTM D 3578 - 00 | Meets |
| Freedom from pinholes | ASTM D 3578 - 00 & FDA 21 CFR 800.20 | Meets |
| Powder-Free | ASTM D 6124 - 00 | < 2 mg/glove |
| Protein Level | ASTM D 5712 - 99 | < 50 µg/g |
| Biocompatibility | Primary Skin Irritation in Rabbits | Passes (Not a primary skin irritant) |
| Biocompatibility | Dermal Sensitization | Passes (Not a contact sensitizer) |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for dimensions, pinholes, etc.). It only references that the tests were performed according to the specified ASTM standards, which would typically define the sampling plans.
The data provenance is from non-clinical performance tests conducted in relation to Malaysian manufacturing by WRP Specialty Products Sdn. Bhd. It is neither prospective nor retrospective clinical data, but rather laboratory testing of the product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this type of device and study. The "ground truth" for the performance characteristics of examination gloves is established by the ASTM and FDA standards themselves, which define measurable, objective criteria (e.g., specific dimensions, tensile strength, protein limits). There are no human experts "establishing ground truth" for each individual test conducted on these gloves in the way that, for example, a radiologist would establish ground truth for an image-based AI device. The tests are based on standardized methodologies and measurements.
4. Adjudication method for the test set:
This information is not applicable. The tests are objective measurements against defined standards. There is no concept of adjudication or consensus among experts for the results of tests like glove dimensions or protein content.
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:
This is not applicable. This is not an AI or imaging device; it is a medical device (examination gloves). Therefore, no MRMC study, human readers, or AI assistance is relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. This is not an AI or algorithm-based device.
7. The type of ground truth used:
The "ground truth" used is defined by verifiable, objective standards and test methodologies. For example:
- Dimensions, Physical Properties, Freedom from Pinholes: Defined by ASTM D 3578 - 00 and FDA 21 CFR 800.20, which specify acceptable ranges for measurements and defect rates.
- Powder-Free: Defined by ASTM D 6124 - 00, specifying a maximum allowable powder residue.
- Protein Level: Defined by ASTM D 5712 - 99, specifying a maximum allowable protein level.
- Biocompatibility: Determined by standardized in vivo tests (Primary Skin Irritation in Rabbits, Dermal Sensitization) that yield objective "Pass/Fail" results based on predefined criteria.
8. The sample size for the training set:
This information is not applicable. This device is not an AI model requiring a training set. The performance evaluation is based on testing a sample of manufactured gloves against established standards.
9. How the ground truth for the training set was established:
This is not applicable. There is no training set for this device.
{0}------------------------------------------------
KO12876
510(k) SUMMARY
1.0 Submitter:
| Name: | WRP Specialty Products Sdn. Bhd. | ||
|---|---|---|---|
| Address: | Lot 11, Jalan 2, Kawasan Perusahaan Bandar Baru SalakTinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA | ||
| Phone No.: | +60 3 8706 9788 | ||
| Fax No.: | +60 3 8706 5020 |
Date of Summary Prepared: 14th August, 2001
2.0 Contact Person:
| Name: | Mr. Mohd Haizan Hussein |
|---|---|
| Phone No.: | +60 3 8706 9788 |
| Fax No.: | +60 3 8706 5020 |
Name of the device: 3.0
| Trade Name: | Powder Free Latex Examination Glove with Aloe Vera andProtein Content Labeling Claim (50 micrograms or less),Non Sterile |
|---|---|
| Common Name: | Examination Gloves |
| Classification Name: | Patient Examination Gloves (per 21 CFR 880.6250) |
Identification of The Legally Marketed Device: 4.0
Class I patient examination gloves, 80LYY, powder free, that meets all the requirements of ASTM standard D 3578 - 00 and FDA 21 CFR 800.20.
5.0 Description of The Device:
.
The Powder Free Latex Examination Glove with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less), Non Sterile meets all the requirements of ASTM Standard D 3578 - 00 and FDA 21 CFR 800.20.
Page 1 of 3
{1}------------------------------------------------
Intended Use of the Device: 6.0
The Powder Free Latex Examination Glove with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less), Non Sterile are disposable devices intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Summary of The Technological Characteristics of The Device: 7.0
The Powder Free Latex Examination Glove with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less), Non Sterile are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICEPERFORMANCE |
|---|---|---|
| Dimensions | ASTM D 3578 - 00 | Meets |
| Physical Properties | ASTM D 3578 - 00 | Meets |
| Freedom from pinholes | ASTM D 3578 - 00FDA 21 CFR 800.20 | Meets |
| Powder-Free | ASTM D 6124 - 00 | < 2 mg/glove |
| Protein Level | ASTM D 5712 - 99 | < 50 µg/g |
| Biocompatability | Primary Skin Irritation inRabbitsDermal Sensitization | Passes(Not a primary skin irritant)Passes(Not a contact sensitizer) |
Substantial Equivalent Based on Assessment of Non-Clinical Performance Data 8.0
The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above.
9.0 Substantial Equivalent Based on Assessment of Clinical Performance Data
Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
{2}------------------------------------------------
10.0 Conclusion
It can be concluded that the Powder Free Latex Examination Glove with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less), Non Sterile will perform according to the glove performance standards referenced in section 7 above and meet ASTM standards, and FDA requirements for water leak test on pinhole AQL. Consequently, this device is substantially equivalent to currently marketed devices.
Page 3 of 3
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with flowing lines, representing the department's mission related to health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 1 2001
Mr. Mohd Haizan Hussein Manager, QA/RA WRP Specialty Products Sdn. Bhd. Lot 11, Jalan 2, Kawasan Perusahaan Bander Baru, Salak Tinggi, Sepang, Selangor MALAYSIA
Re: K012876
Trade/Device Name: Dermagrip Powder Free Latex Examination Gloves with Aloe Vera and Protein Content Labeling Claim (50 Micrograms or Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: August 14, 2001 Received: August 27, 2001
Dear Mr. Hussein:
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.
{4}------------------------------------------------
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,
Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
{5}------------------------------------------------
INDICATIONS FOR USE
Applicant:
WRP Specialty Products Sdn Bhd
510(k) Number (if known):
(
Device Name:
POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS), NON STERILE
Indications For Use:
The Powder Free Latex Examination Gloves with Aloe Vera and Protein Content The Fowder I roo Daton Endimans or less), Non Sterile is a disposable device Labeling Claim (20 micrograms of 1000), 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)
Over-The-Counter _____________________________________________________________________________________________________________________________________________________________ OR
Olin S. him
(Division Sign-Off) Division of Dental, Infection Contr and General Hospital 510(k) Number
§ 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.