(152 days)
Not Found
Not Found
No
The device description and performance studies focus on physical characteristics, leakage, and biocompatibility, which are standard for examination gloves and do not indicate the use of AI/ML. There are no mentions of AI, ML, image processing, or data sets related to AI/ML training or testing.
No
The device, a disposable examination glove, is intended to prevent contamination between patient and examiner, falling under the category of barrier protection rather than directly treating or mitigating a disease or condition.
No
Explanation: The device is a disposable glove intended to prevent contamination between the patient and examiner, not to diagnose a medical condition. Its function is barrier protection, not medical assessment or detection.
No
The device description clearly states it is a "light and flexible glove," which is a physical hardware component, 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 to prevent contamination between patient and examiner by being worn on the hand(s) or finger(s). This is a barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description of a light and flexible glove for examination procedures aligns with a barrier device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on physical characteristics, leakage, and biocompatibility, which are relevant for a barrier device, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Disposable device intended for medical purposes that is worn on the examiner's hand(s) or finger(s) to prevent contamination between patient and examiner.
Product codes
LYY
Device Description
Product is a light and flexible glove, in standard sizes, for use in examination procedures, sold non-sterile and intended to be disposed of after use with each patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand(s) or finger(s)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
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
Summary of Test Data Used in Determining Equivalence: Physical Characteristics, before and after aging. Evaluation of Leakage. Primal Dermal Irritation. Maximization Sensitization (ISO)
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.
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APR 21 1998
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
- Submitter: George Q. Kuo, M.D., CLK International, Inc., 28 East Broadway, 1. 2nd Floor, New York, NY, 10002. Ph: (212) 334-3953
- Classification Names and Numbers: Latex "Powder-Free" Examination Glove, 11. 80LYY, Class I
- Common/Usual Name: Latex "Powder-Free" Examination Glove (11.
- Proprietary Names: CLK Int'l. Powder Free Latex Examination Glove IV.
- Establishment Registration Number: In Progress V.
- VI. Classification: Class I
VII. Performance Standard:
None established under section 514. Meets ASTM D3578 voluntary standards.
VIII. Description of the Device:
Product is a light and flexible glove, in standard sizes, for use in examination procedures, sold non-sterile and intended to be disposed of after use with each patient.
IX. Substantial Equivalent:
The CLK International glove is substantially equivalent to latex powder-free examination gloves cleared under the premarket-510(k)process since about 1990. It complies with the required standard (see above) as do equivalent gloves. Characteristics of the CLK Int'l latex powder-free examination gloves are compared with ASTM D3578 in Attachment I, Table I.
The "510(k) Substantial Evidence" Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed as described below:
-
- These products have the same intended use, a disposable device intended for medical purposes that is worn on the examiner's hand(s) or finger(s) to prevent contamination between the patient and the examiner. These are the same as those of the predicate devices. These products also have the same intended uses as similar products cleared for marketing by the 510(k) process.
-
- The technical characteristics for this product are the same as those for the predicate devices and those currently on the market that are prepared from rubber materials.
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- The technical characteristics for this product are the same as those for the 2. predicate devices and those currently on the market that are prepared from rubber materials.
- Descriptive information provided shows that the materials from which the CLK 3. latex powder-free examination gloves made are substantially equivalent to (nearly identical with) those of similar products and are to be used for identical purposes, currently on the market. Tests show they meet the requirements of ASTM D3578 for latex examination gloves.
- The FDA "Decision-Making Process" chart was used and appears in 4. Attachment V.
Data used in determining substantial equivalence include those required by ASTM D3578 and biocompatability test data as required by Int. Std ISO-10993 as modified by the FDA in the General Program Memorandum #G95-1.
Summary of Test Data Used in Determining Equivalence: Physical Characteristics, before and after aging. Evaluation of Leakage. Primal Dermal Irritation. Maximization Sensitization (ISO)
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three profiles facing right, representing the human aspect of the department's work. The profiles are connected by flowing lines, creating a sense of unity and continuity.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1 1998
George Q. Kuo, M.D. President CLK International, Incorporated 28 East Broadway, 2nd Floor New York, New York 10002
K974371 Re : CLK International Powder-Free Latex Trade Name: Examination Glove Requlatory Class: I Product Code: LYY March 30, 1998 Dated: Received: March 31, 1998
Dear Dr. Kuo:
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 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 general controls provisions The general controls provisions of the Act 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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements 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 through 542 of
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Page 2 - Dr. Kuo
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA asboing 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" (21 CFR 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.fdag.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A Ulatowski Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
| Applicant: | CLK International, Inc. |
|---|---|
| 510(k) Number: | Not Applicable K974371 |
| POWDER FREE | |
| Device Name: | CLK Intl. Latex Patient Examination Glove |
| Indications for use: |
Disposable device intended for medical purposes that is worn on the examiner's hand(s)
or finger(s) to prevent contamination between patient and examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
14 1 17 (Division Sign-Off) Division of Dental, Infection Control, and General Huapital Devices 510(k) Nymbar OR
Prescription Use Per 21 CFR 801.109
3.0
Over-The-Counter (Optional Format 1-2-96)
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