(67 days)
Not Found
Not Found
No
The device is a standard examination glove and the summary does not mention any AI or ML capabilities.
No
The device is described as an examination glove intended to be a barrier against contaminants, not to provide therapy or treatment.
No
Explanation: The device is described as a "powder free latex examination glove" intended to be worn on the hand for medical purposes to provide a barrier. This function is protective and not for diagnosing a condition or disease.
No
The device is a physical examination glove made of natural rubber latex, not software. The description focuses on material properties and physical standards.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of this device is to be worn on the hand as a barrier.
- IVDs are used to provide information about a physiological state, health, or disease. This device provides a physical barrier, not diagnostic information.
- The description focuses on physical properties and barrier function. There is no mention of analyzing biological samples or providing diagnostic results.
This device is a medical device, specifically a Class I medical device (general controls) in the US, intended for barrier protection during medical procedures.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LYY
Device Description
Powder Free Natural Rubber Latex Examination Gloves, Blue Color, Non-Sterile will meet all the current specification for ASTM D3578.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical purposes
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
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. (referring to comparisons against ASTM standards for dimensions, physical properties, freedom from pin-holes, powder free residue, soluble protein level, biocompatibility (dermal sensitization and primary skin irritation)). Clinical data are not needed for market cleared examination gloves.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
Not Found
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).
Not Found
§ 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.
0
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
1
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
2
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
3
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.
4
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
5
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 per | ||
| dm² of glove or less of water soluble protein. | ||
| Indication For Use: | 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. |
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