(69 days)
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No
The document describes standard examination gloves and contains no mention of AI or ML technology.
No
The device is a medical glove, a barrier against contaminants, not a device intended for therapy or treatment.
No
Explanation: The device is a latex examination glove, intended for use as a barrier to provide protection against infectious materials and contaminants, not for diagnostic purposes.
No
The device is a physical examination glove made of latex, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants. This describes a physical barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description focuses on the material (latex), coating (polymer), and physical properties (powder-free, protein labeling, meeting ASTM standards). It does not describe any components or processes related to analyzing samples or providing diagnostic information.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic results.
IVD devices are designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This glove does not fit that description.
N/A
Intended Use / Indications for Use
The Powder Free Polymer Coated Latex Examination Gloves, Non-Sterile, with Protein Labeling claim of 50 micrograms per dm2 of glove or less of water soluble protein 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.
A powder free polymer coated 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.
Product codes (comma separated list FDA assigned to the subject device)
LYY
Device Description
The Powder Free Polymer Coated Latex Examination Gloves, Non-Sterile, with Protein Labeling claim of 50 micrograms per dm2 of glove or less of water soluble protein will meet all the current specification for ASTM D3578.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
hand
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance test data that support a determination of substantial equivalence are described above.
Clinical data are not needed for market cleared examination gloves.
It can be concluded that the Powder Free Polymer Coated Latex Examination Gloves, Non-Sterile, with Protein Labeling claim of 50 micrograms per dm2 of glove or less of water soluble protein 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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WSIVE Wear Safe (Malaysia) Sdn.Bhd. (Company No.204396-X)
OCT 2 1 2009
FDA 510(k), Premarket Notification : 510(k) Summary of Safety and Effectiveness Information
1.0 Submitter:
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:
| Contact: | Mr. SH TAN |
|---|---|
| E-mail: | shtan@kossan.com.my |
| Telephone No.: | +603 3291 2657 |
| Fax No.: | +603 3291 0584 |
3.0 Name of Device:
Trade Name: Powder Free Polymer Coated Latex Examination Gloves, Non-Sterile, with Protein Labeling claim of 50 micrograms per dm- of glove or less of water soluble protein. Common Name: Patient Examination Glove Classification Name: Patient Examination Glove.
4.0 Identification of The Legally Marketed Device:
The Powder Free Polymer Coated Latex Examination Gloves, Non-Sterile, with Protein Labeling claim of 50 micrograms per dm2 of glove or less of water soluble protein, Class I Patient Examination gloves, 80LYY, meets all of the requirements of ASTM D3578 Standard Specification for Rubber Examination Gloves.
રું છ Description of Device:
The Powder Free Polymer Coated Latex Examination Gloves, Non-Sterile, with Protein Labeling claim of 50 micrograms per dm2 of glove or less of water soluble protein 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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WSM Wear Safe (Malaysia) Sdn.Bhd. (Company No.204396-X)
6.0 Intended Use of the Device:
The Powder Free Polymer Coated Latex Examination Gloves, Non-Sterile, with Protein Labeling claim of 50 micrograms per dm2 of glove or less of water soluble protein 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
The Powder Free Polymer Coated Latex Examination Gloves, Non-Sterile, with Protein Labeling claim of 50 micrograms per dm of glove or less of water soluble protein 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 5¼ Off Jalan Meru, 41050 Klang, Selangor Darul Ehsan Malaysia. Tel: 603-33923088, Fax: 603-33922599
2
WSIVI Wear Safe (Malaysia) Sdn.Bhd. (Company No.204396-X)
f
10.0 Conclusion
It can be concluded that the Powder Free Polymer Coated Latex Examination Gloves, Non-Sterile, with Protein Labeling claim of 50 micrograms per dm2 of glove or less of water soluble protein 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.
Lot 13726, Jalan Haji Salleh, Batu 5¼ Off Jalan Meru, 41050 Klang, Selangor Darul Ehsan Malaysia. Tel: 603-33923088, Fax: 603-33922599
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", indicating the department's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Mr. SH. Tan Regulatory Affairs Department Manager Wear Safe (MALAYSIA) SDN. BHD. Lot PT 13726, Jalan Haji Salleh, Off Jalan Meru Klang, Selangor, Darul Ehsan MALAYSIA 41050
OCT 2 1 2009
Re: K092492
Trade/Device Name: Powder Free Polymer Coated Latex Examination Gloves, Non-Sterile, with Protein Labeling Claim of 50 Micrograms Per dm2 of Gloves or Less of Water Soluble Protein.
Regulation Number: 21 CFR 880.6250
Regulation Name: Patient Examination Glove
Regulatory Class: I
Product Code: LY Y
Dated: September 25, 2009
Received: September 29, 2009
Dear Mr. Tan:
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 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
Page 2- Mr. Tan
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/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.
http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.
Sincerely yours,
11.02.2017 11:12 0 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
Inthing O. Water for Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
WSM Wear Safe (Malaysia) Sdn.Bhd. (Company No.204396-X)_
INDICATIONS FOR USE
Applicant:
WEAR SAFE (MALAYSIA) SDN. BHD.
510(k) Number (if known): K092492
Device Name:
Powder Free Polymer Coated Latex Examination Gloves, Non-Sterile, with Protein Labeling claim of 50 micrograms per dm2 of glove or less of water soluble protein.
Indication For Use:
A powder free polymer coated 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.
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)
Shula M. Murphy, MD
(Division Sign-Off)
Tivision of Anesthesiology, General Hospital nfection Control, Dental Devices
Page 1 of 1
10(k) Number: K092442
Lot 13726, Jalan Haji Salleh, Batu 5¼ Off Jalan Meru, 41050 Klang, Selangor Darui Ehsan Malaysia. Tel: 603-33923088, Fax: 603-33922599