(67 days)
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSES WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER: CANAD
DISPOSABLE VINYL EXAM GLOVES, POWDERED
This is a letter from the FDA to Shanghai Antares Industries, Incorporated regarding their Disposable Vinyl Exam Gloves, Powdered. The letter approves the device for marketing and indicates it is substantially equivalent to legally marketed predicate devices. The "Indications for Use" section specifies the intended purpose of the gloves.
Here's an analysis based on the provided text for the acceptance criteria and study, though not all requested information is present as this is a regulatory approval document and not a scientific study report:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Indications for Use: Prevent contamination between patient and examiner. | "A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSES WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER." (This is the stated intended use, implying the device performs this function.) |
| Material: Disposable Vinyl | "DISPOSABLE VINYL EXAM GLOVES, POWDERED" (Matches the device description.) |
| Form: Powdered Exam Gloves | "DISPOSABLE VINYL EXAM GLOVES, POWDERED" (Matches the device description.) |
Note: This document does not provide quantifiable performance metrics (e.g., tensile strength, barrier efficacy rates) that would typically be part of a detailed acceptance criterion table for a medical device. It primarily focuses on the regulatory clearance based on substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance
- The document does not specify a sample size used for a test set. This is a 510(k) premarket notification approval, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed new clinical study data for device performance.
- The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data. The submission is from Shanghai Antares Industries, Incorporated, China, P.R.C., suggesting any supporting data would likely originate from there or be based on existing literature/predicate device data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the document. For a 510(k) submission, the "ground truth" often relates to the established performance and safety profile of the predicate device, or adherence to recognized standards.
4. Adjudication method for the test set
- The document does not describe any adjudication method for a test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This is not applicable to this device (disposable vinyl exam gloves). This type of study is relevant for diagnostic imaging or AI-assisted interpretation tools, not for basic medical consumables. No MRMC study was done or reported.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This is not applicable to this device. No algorithm or AI component is mentioned or relevant to disposable exam gloves.
7. The type of ground truth used
- The implicit "ground truth" for a 510(k) submission like this is typically the established safety and effectiveness of the legally marketed predicate device to which the new device is compared as "substantially equivalent." It also relies on adherence to relevant manufacturing practices (GMP) and general controls. There is no mention of pathology, outcome data specific to this device, or expert consensus in the context of a new study for this specific approval.
8. The sample size for the training set
- The document does not specify a training set sample size. This concept is typically relevant for machine learning algorithms, which are not applicable here.
9. How the ground truth for the training set was established
- This is not applicable as there is no mention of a training set or machine learning.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUM" on the left side and "SERVICES-USA" on the right side. Inside the circle is a stylized image of three human profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 9 1998
Mr. John Lai ·Sales Executive Shanghai Antares Industries, Incorporated No. 259, Yushu Road, Canqqiao Township Songjiang County, Shanghai, CHINA, P.R.C.
Re : K982687 Disposable Vinyl Exam Gloves, Powdered Trade Name: Regulatory Class: I Product Code: LYZ Dated: July 8, 1998 Received: August 3, 1998
Dear Mr. Lai:
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 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 regulation 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Lai
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 labelinq 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 gener 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/dsmamain.html".
Sincerely yours,
Timothy A. 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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4
- 3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page The information, data and labeling claims in the entire the 510(k) submission must support an agree with the Indications for Use statement.
INDICATIONS FOR USE
| Applicant: | SHANGHAI ANTARES INDUSTRIES, INC. |
|---|---|
| 510(k) Number (if known): | K982687 |
| Device Name: | DISPOSABLE VINYL EXAM GLOVES,POWDERED |
| Indications For Use: |
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSES WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER: CANAD
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)
Olin S. Cum
(Division Sign-Off)
Division . i. cial, Infection Control, and General Hospital Devices 510(k) Number
Prescription Use OR Per 21 CFR 801.109 (Optional Format 1-2-96)
Over-The-Counter
For a new submission, do NOT fill in the 510(k) number blank. 좋
PAGE ADD 2-1
§ 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.