(176 days)
Not Found
Not Found
No
The 510(k) summary describes standard latex examination gloves and makes no mention of AI, ML, or any related technologies.
No.
Explanation: The device is a glove intended as a barrier against contamination, not for treating a disease or condition.
No
The device, Blue Powder Free Latex Examination Gloves, is described as a barrier to protect against infectious materials, not to diagnose medical conditions.
No
The device is described as a physical product made from natural rubber latex compound, intended to be worn on the hands. It is a tangible medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "to be worn on the hands as a barrier against potentially infectious materials and other contamination." This describes a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description is for "Latex Patient Examination Gloves," which are a physical barrier device.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
Therefore, this device falls under the category of a medical device used for protection and barrier purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
A medical glove is worn on the hands of healthcare and similar personnel as a barrier against potentially infectious materials and other contamination between healthcare and patient's body, fluid, waste or environment.
Blue Powder Free Latex Examination Gloves, Non-Sterile is a disposable medical device made from natural rubber latex compound. It is intended to be worn on the hands as a barrier against potentially infectious materials and other contamination.
Product codes
LYY
Device Description
Latex Patient Examination Gloves, LYY, Powder Free
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare and similar personnel
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- The Quality performance of the glove are shown in the table above 6. meets ASTM D 3578-01 Standard and FDA's requirement
-
- The Biocompatibility Test consists of Primary Dermal Irritation Study And the Dermal Sensitization Study. The gloves pass the Biocompatibility Test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Latex Patient Examination Gloves LYY, Powder Free
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
17.0 SMDA 510(K) SUMMARY
":"1" | "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "| "
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FEB 2 0 2007
| 1. Applicant | MULTISAFE SDN. BHD
Lot 764, Bidor Industrial Estates,
35500 Bidor,
Perak Darul Ridzuan,
Malaysia. |
|--------------------------|---------------------------------------------------------------------------------------------------------------|
| Tel No. | 605-4348269 |
| Fax No | 605-4348266 |
| Name of Contact Person | 1. Mr. Abd Hadi bin Husin
2. Ms. Rosnani Binti Hassan Besari |
| Date of Summary Prepared | 10th August 2006 |
| 2. Name of Device | |
| Trade Name | Blue Powder Free Latex Examination
Glove, Non-Sterile |
| Common Name | Examination Gloves |
| Classification Name | Patient Examination Gloves (Class 1 in
US and European markets, Class IIa in
Canadian Market) |
3. Identification Of the Legally Marketed Devices
Latex Patient Examination Gloves LYY, Powder Free that meets all the requirements of FDA, ASTM D 3578, ISO 11193, EN 455 : Part 1, Part 2 and Part 3, CMDR, MDR and CGSB.
1
Description Of the Devices 4.
Latex Patient Examination Gloves, LYY, Powder Free
5. The Intended Use of Glove
A medical glove is worn on the hands of healthcare and similar personnel as a barrier against potentially infectious materials and other contamination between healthcare and patient's body, fluid, waste or environment.
- The Quality performance of the glove are shown in the table above 6. meets ASTM D 3578-01 Standard and FDA's requirement
-
- The Biocompatibility Test consists of Primary Dermal Irritation Study And the Dermal Sensitization Study. The gloves pass the Biocompatibility Test.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes representing the agency's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 0 2007
Mr. Abd Hadi Bin Husin Plant Manager MultiSafe Sdn. Bhd. Lot 764, Bidor Industrial Estate, 35500 Bidor, Perak MALAYSIA
Re: K062527
Trade/Device Name: Blue Powder Free Latex Examination Gloves, Non-Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: January 15, 2007 Received: January 26, 2007
Dear Mr. Husin:
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.
3
Page 2 - Mr. Husin
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), please contact the Office of Compliance at (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Ching-Lin, Ph.D.
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Applicant :
MULTISAFE SDN. BHD Lot 764, Bidor Industrial Estate, 35500 Bidor, Perak, Malaysia.
Tel No : 605-4348269 Fax No : 605-4348266
510(k) Number (if known) :
KOG2527
Device Name : Blue Powder Free Latex Examination Gloves, Non-Sterile
Indication for Use :
Blue Powder Free Latex Examination Gloves, Non-Sterile is a disposable medical device made from natural rubber latex compound. It is intended to be worn on the hands as a barrier against potentially infectious materials and other contamination.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 -
Elaine S. Mayhall for S. Murphy
062527