(81 days)
Not Found
Not Found
No
The device is a latex examination glove, and the summary contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device, CIR latex examination gloves, is intended to prevent contamination between healthcare personnel and patients. It does not provide any therapeutic benefit or treatment to a patient.
No
The device, CIR latex examination glove, is used to prevent contamination and is not involved in diagnosing medical conditions.
No
The device described is a physical medical device (latex examination gloves) and does not involve any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the glove is worn on the hand to prevent contamination between healthcare personnel and the patient's body, fluids, waste, or environment. This is a barrier function, not a diagnostic function.
- Device Description: The description identifies it as a "Latex Examination Glove." Examination gloves are personal protective equipment (PPE) used for barrier protection, not for performing tests on samples from the human body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This glove does not fit that description.
N/A
Intended Use / Indications for Use
CIR latex examination glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste, or environment.
Product codes
LYY
Device Description
CIR Latex Gloves, Non-Sterile, Powdered [Latex Examination Gloves (Powdered, Non-Sterile) with Protein Labeling Claim of ≤ 200 µg/g]
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY | 8 1998
Mr. Chong Lee Chuan QA/Technical Manaqer Crocker Industrial Resources Sdn. Bhd. PLO 38, Senai Industrial Area, Phase 2, 81400 Senai, Johor MALAYSIA
Re : K980754 Trade Name: Cir Latex Examination Gloves, Non-Sterile, Powdered, with Protein Labeling Claim of 200uq/q or Less Regulatory Class: I Product Code: LYY Dated: February 23, 1998 Received: February 26, 1998
Dear Mr. Chong Lee Chuan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the qeneral 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 (Premarket Approval), 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 895. ਕੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Mr. Chong Lee Chuan
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Timothy A. Ulatowski
Timoth Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
Crocker Industrial Resources Sdn. Bhd. PLO 38, Senai Industrial Area, Phase 2, 81400 Senai, Johor, Malaysia. Tel : (607)-5996861/2 Fax : (607)-5996863 E-mail : cir@tm.net.my
510K No. : K980754
Device Name : CIR Latex Gloves, Non-Sterile, Powdered [Latex Examination Gloves (Powdered, Non-Sterile) with Protein Labeling Claim of ≤ 200 µg/g]
Indication for Use :
Pre (Pe
CIR latex examination glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste, or environment.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
per 21 CFR 801,109) | OR | Over-The-Counter-Use
(Optional Format 1-2-96) | X |
| ----------------------------------------- | ---- | -------------------------------------------------- | --- |
|---|
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number