(38 days)
INTENDED FOR MEDICAL PURPOSES WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
PVC SYNTHETIC EXAMINATION GLOVES, POWDERED DISPOSABLE
This document is a 510(k) clearance letter from the FDA for "PVC (Polyvinyl Chloride) Synthetic Examination Gloves, Powdered." It is not a study report for a novel medical device like AI software or an implant, but rather a clearance for a relatively simple disposable medical examination glove. Therefore, most of the questions regarding acceptance criteria, study design, and performance metrics (like sample size, ground truth, expert qualifications, MRMC studies, etc.) are not applicable in the typical sense for a 510(k) clearance of this type of device.
For a device like examination gloves, the "acceptance criteria" are generally related to manufacturing standards, material safety, and performance characteristics such as barrier integrity and strength, rather than diagnostic accuracy or clinical outcomes in the same way an AI algorithm would be evaluated. The "study" proving the device meets a criteria would typically involve laboratory testing rather than a clinical trial with human subjects for efficacy.
Here's an attempt to answer the questions based on the provided document and general understanding of 510(k) clearances for examination gloves:
1. A table of acceptance criteria and the reported device performance
The provided document (a 510(k) clearance letter) does not contain a table of acceptance criteria or reported device performance in the same manner as a clinical study report for an AI device. For examination gloves, acceptance criteria are typically derived from recognized consensus standards (e.g., ASTM standards for medical gloves) related to:
- Physical Properties: Tensile strength, elongation at break.
- Barrier Integrity: Freedom from holes (e.g., Water Leak Test, Air Leak Test).
- Dimensions: Length, width, thickness.
- Biocompatibility: Absence of irritation, sensitization, or cytotoxicity (usually tested according to ISO 10993 series).
- Level of Powder (if powdered).
The 510(k) process for examination gloves relies on demonstrating substantial equivalence to a predicate device. This implies that the new device meets the same performance standards as legally marketed predicate devices. The specific quantitative acceptance criteria and the Shanghai Palomar Mountain Industries, Incorporated glove's performance against these criteria are not detailed in this FDA clearance letter. These details would be in the applicant's 510(k) submission.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable directly from the provided document. For physical and barrier integrity testing of gloves, sample sizes are typically determined by statistical sampling plans (e.g., AQL levels for attributes data) from manufacturing batches. The country of origin for the data would be China (where the manufacturer is located), and such testing is generally prospective, occurring during or after manufacturing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. For examination gloves, "ground truth" is established through standardized laboratory tests (e.g., observing for leaks, measuring tensile strength) by trained technicians or quality control personnel, not subjective expert opinion.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers/experts, which isn't relevant for objective laboratory testing of gloves.
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
Not applicable. MRMC studies are for evaluating diagnostic accuracy with and without AI assistance, which is irrelevant for examination gloves.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. "Standalone" performance is a concept for AI or automated diagnostic devices. This device is a physical barrier protection device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For examination gloves, the "ground truth" for performance is established by objective, standardized laboratory test methods (e.g., ASTM D6319 for PVC gloves, which specifies tests for physical dimensions, ultimate tensile strength, elongation, and watertight integrity via visual inspection for leaks).
8. The sample size for the training set
Not applicable. There is no "training set" in the context of examination glove evaluation as it's not a machine learning or AI device. Manufacturing processes are honed over time, but this isn't a "training set" in the computational sense.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its back, enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 29 1999
Mr. Danny Wang Manager Shanghai Palomar Mountain Industries, Incorporated No. I, Biyu Road, Cangqiao Township Songjiang County, Shanghai, CHINA, P.R.C.
Re : K992100 PVC (Polyvinyl Chloride) Synthetic Trade Name: Examination Gloves, Powdered Regulatory Class: I Product Code: LYZ April 26, 1999 Dated: Received: June 21, 1999
Dear Mr. Wang:
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 reqistration, 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Wang
this response to your premarket notification Please note: 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.
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 requlation (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.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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- 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 and agree with the Indications for Use statement.
INDICATIONS FOR USE INDICATIONSTONSTON PALOMAR MOUNTAIN INDUSTRIES, INC. 992100 510(k) Number (if known): * PVC SYNTHETIC EXAMINATION GLOVES, POWDERED Device Name: DISPOSABLE Indications For Use: INATION GLOVE IS A DISPOSABLE DEVICE A PATIENT
INTENDED FOR MEDICAL PURPOSES WORN ON THE EXAMINER'S HAND OR FINGER 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)
Prescription Use OR Per 21 CFR 801.109
Over-The-Counter X
(Optional Format 1-2-96)
For a new submission, do NOT fill in the 510(k) number blank.
Qais. Lim
(Division Sign-Off) wision of Dental, Infection t
§ 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.