(67 days)
A powder free latex examination glove is a disposable device made of natural rubber material intended to be worn on the hand for medical purposes to provide barrier against potentially infectious materials and other contaminants.
Powder Free Natural Rubber Latex Examination Gloves, Blue Color, Non-Sterile will meet all the current specification for ASTM D3578.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder Free Natural Rubber Latex Examination Gloves:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Standards / Acceptance Criteria | Device Performance |
|---|---|---|
| Dimensions | ASTM D3578 - 05 | Meets |
| Physical Properties | ASTM D 412 - 06ae1 | Meets |
| Freedom from pin-holes | ASTM D 5151 - 06 | Meets |
| Powder Free Residue | ASTM D 6124 - 06 | Meets |
| Soluble Protein Level | ASTM D 5712 - 05 (also protein labeling claim of 50 micrograms per dm² of glove or less) | Meets (with protein labeling claim of 50 micrograms per dm² of glove or less) |
| Biocompatibility: | ||
| - Dermal Sensitization | Dermal Sensitization (as per ASTM F720-81) | Not a contact skin sensitizer |
| - Skin Irritation | Primary Skin Irritation Test (as per 16CFR Part1500) | Not a primary skin irritant |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the specific sample sizes used for each of the tests (Dimensions, Physical Properties, Freedom from pin-holes, Powder Free Residue, Soluble Protein Level, Biocompatibility).
The data provenance is not specified beyond indicating these are "performance test data." It is highly likely these were conducted as prospective tests by the manufacturer, specifically for this submission. The country of origin of the data would be Malaysia, where WEAR SAFE (MALAYSIA) SDN. BHD. is located and conducted the testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The tests performed are objective, laboratory-based physical and chemical assays, and biocompatibility tests. They rely on standardized methods rather than expert interpretation of data like in an imaging study. Therefore, the concept of "experts establishing ground truth" in the way it might apply to medical imaging or diagnostics is not directly relevant here. The ground truth for these tests is defined by the objective measurement criteria of the specified ASTM and CFR standards.
4. Adjudication method for the test set:
Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments where multiple readers might disagree on findings (e.g., radiologists interpreting images). Since these are objective physical, chemical, and biocompatibility tests, no adjudication method in this sense would have been used. The results are based on direct measurements and observations according to the test protocols.
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:
No MRMC comparative effectiveness study was done. This device is a patient examination glove, a physical product, not an AI-powered diagnostic or assistive technology. The concept of "human readers improving with AI assistance" is not applicable to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
No standalone algorithm performance study was done. This is a physical non-AI device.
7. The type of ground truth used:
The ground truth for these tests is based on objective measurement criteria and thresholds defined by established international standards:
- ASTM D3578-05 for Dimensions
- ASTM D 412-06ae1 for Physical Properties
- ASTM D 5151-06 for Freedom from pin-holes
- ASTM D 6124-06 for Powder Free Residue
- ASTM D 5712-05 for Soluble Protein Level
- ASTM F720-81 for Dermal Sensitization
- 16CFR Part 1500 for Primary Skin Irritation Test
These standards specify the methodology and acceptable limits for each characteristic.
8. The sample size for the training set:
Not applicable. This device is a physical product, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
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K100799/5001
FDA 510(k), Premarket Notification : 510(k) Summary of Safety and Effectiveness Information
1.0 Submitter:
ર
++
WEAR SAFE (MALAYSIA) SDN. BHD. Lot PT 13726, Jalan Haji Salleh, Off Jalan Meru, 41050 Klang, Selangor Darul Eshan, Malaysia.
Telephone No .: +603 3392 3088 Fax No.: +603 3392 2118
2.0 Contact Person:
- SEP 3 2010
| Contact: | Mr. Mohd Azlan |
|---|---|
| E-mail: | azlan@kossan.com.my |
| Telephone No.: | +603 3392 3088 |
| Fax No.: | +603 3392 2599 |
3.0 Name of Device:
| Trade Name: | Powder Free Natural Rubber Latex Examination Gloves, Blue Color, Non-Sterile |
|---|---|
| Common Name: | Patient Examination Glove |
| Classification Name: | Patient Examination Glove. |
Identification of The Legally Marketed Device: 4.0
Powder Free Natural Rubber Latex Examination Gloves, Blue Color, Non-Sterile Class I Patient Examination gloves, 80LYY, meets all of the requirements of ASTM D3578 Standard Specification for Rubber Examination Gloves.
Description of Device: 5.0
Powder Free Natural Rubber Latex Examination Gloves, Blue Color, Non-Sterile will meet all the current specification for ASTM D3578.
Lot 13726, Jalan Haji Salleh, Batu 5¼ Off Jalan Meru, 41050 Klang, Selangor Darul Ehsan Malaysia. Tel: 603-33923088, Fax: 603-33922599
Page 1 of 3
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Intended Use of the Device: 6.0
i
Powder Free Natural Rubber Latex Examination Gloves, Blue Color, Non-Sterile is a disposable device intended for medical purposes that is intended to be worn on the hand for medical purposes to provide barrier against potentially infectious materials and other contaminants.
Summary of The Technological Characteristics of The Device: 7.0
Powder Free Natural Rubber Latex Examination Gloves, Blue Color, Non-Sterile possesses the following technological characteristic (as compared to ASTM or equivalent standards):
| Characteristic | Standards | Device Performance |
|---|---|---|
| Dimensions | ASTM D3578 - 05 | Meets |
| Physical Properties | ASTM D 412 - 06ae1 | Meets |
| Freedom from pin-holes | ASTM D 5151 - 06 | Meets |
| Powder Free Residue | ASTM D 6124 - 06 | Meets |
| Soluble Protein Level | ASTM D 5712 - 05 | Meets |
| Biocompatibility | Dermal Sensitization(as per ASTM F720-81) | Not a contact skin sensitizer |
| Primary Skin Irritation Test(as per 16CFR Part1500) | Not a primary skin irritant |
Substantial Equivalent Based on Assessment of Non-Clinical Performance Data 8.0
The performance test data that support a determination of substantial equivalence are described above.
Substantial Equivalent Based on Assessment of Clinical Performance Data 9.0
Clinical data are not needed for market cleared examination gloves.
Lot 13726, Jalan Haji Salleh, Batu 5½ Off Jalan Meru, 41050 Klang, Selangor Darul Ehsan Malaysia. Tel: 603-33923088, Fax: 603-33922599
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10.0 Conclusion
It can be concluded that the Powder Free Natural Rubber Latex Examination Gloves, Blue Color, Non-Sterile is safe and effective for use and will perform according to the glove performance standards referenced in Section 7 above, thereby meeting ASTM standards, FDA requirements, and the labeling claims for the product.
Consequently, this device is substantially equivalent to current marketed devices.
This summary will include any other information reasonably deemed necessary by the FDA.
Prepared By : Mohd Azlan
Date : May 18, 2010
Lot 13726. Jalan Haji Salleh. Batu 5¼ Off Jalan Meru, 41050 Klang, Selangor Darul Ehsan Malaysia. Tel: 603-33923088, Fax: 603-33922599
Page 3 of 3
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DEPARTMENT OF HEALTH & HUMAN SERVICES
· Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Mohd Azlan Quality Assurance Manager Wear Safe (Malaysia) SDN. BHD. Lot PT 13726, Jalan Haji Salleh, Off Jalan Meru Klang, Selangor Darul Ehsan Malaysia 41050
2010 SEP 3
Re: K101799
Trade/Device Name: Powder Free NR Latex Examination Gloves Blue (Colored), Non-Sterile, with Protein Labeling claim of 50 micrograms per dm of glove or less of water soluble protein.
Regulation Number: 21 CFR 880.6250
Regulation Name: Patient Examination Glove
Regulatory Class: I
Product Code: LYY
Dated: August 20, 2010
Received: August 24, 2010
Dear Mr. Azlan:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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Page 2- Mr. Azlan
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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor.You/Industry/default.htm.
Sincerely vours.
Anthony D. Watson, B.S., M.S., M.B.A.
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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Wear Safe (Malaysia) Sdn.Bhd. (Company No.204396-X)
K 101799/5001
INDICATIONS FOR USE
| Applicant: | WEAR SAFE (MALAYSIA) SDN. BHD. | SEP 3 2010 |
|---|---|---|
| 510(k) Number (if known): | ||
| Device Name: | Powder Free NR Latex Examination Gloves Blue (Colored),Non-Sterile, with Protein Labeling claim of 50 micrograms perdm² of glove or less of water soluble protein. | |
| Indication For Use: | A powder free latex examination glove is a disposable devicemade of natural rubber material intended to be worn on thehand for medical purposes to provide barrier against potentiallyinfectious materials and other contaminants. |
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth &, Mamie-Williams
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K101799 Page 1 of 1
Lot 13726, Jalan Haji Salleh, Batu 5½ Off Jalan Meru, 41050 Klang, Selangor Darul Ehsan Malaysia. Tel: 603-33923088, Fax: 603-33922599
§ 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.