(186 days)
A patient examination glove is a disposable Device,intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and cxaminer.
Class I vinyl patient examination gloves 80LYZ,powder-free,that meets all the requirements of ASTM D 5250-00.
This document is a 510(k) Pre-market Notification for a medical device, specifically Vinyl Patient Examination Gloves, Powder-Free. It outlines the device's technical characteristics and intended use but does not contain information about a study proving the device meets specific acceptance criteria related to diagnostic accuracy or AI performance.
The information provided pertains to the physical and biocompatibility properties of the gloves, comparing them to an ASTM standard. It's a regulatory submission for a Class I medical device, which typically involves demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical trial proving diagnostic performance.
Therefore, I cannot provide answers to the questions you've asked regarding acceptance criteria related to diagnostic accuracy, AI performance, sample sizes for test/training sets, expert consensus, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the information presented in the provided text.
The closest relevant information, regarding "acceptance criteria" for this device, would be the physical requirements outlined for the gloves to meet the ASTM D 5250-00 standard for patient examination gloves.
Here's an attempt to fill in the table with the available physical requirements and implied performance:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (from ASTM D 5250-00, as stated) | Reported Device Performance (ZHONGHONG) |
|---|---|
| Width Tolerance (for sizes S, M, L, XL) | $\pm$ 5 mm |
| Length (for sizes S, M, L, XL) | min 230 mm |
| Tensile Strength (Mpa, min) (Before & after accelerated aging) | 9.0 Mpa |
| Biocompatibility Data | Not explicitly stated for specific metrics, but "are conducted on the polymer coated vinyl gloves." |
| Powder-free status | Implicitly required as a "Powder-free" device |
Regarding the other questions, based on the provided text, the answers are N/A (Not Applicable) or "Information Not Provided":
- 2. Sample sized used for the test set and the data provenance: N/A. This document describes the physical properties of gloves, not a diagnostic device with a "test set" in the context of clinical performance data. The testing is for physical properties (e.g., batch testing for dimensions, tensile strength). Data provenance is from "TANGSHAN ZHONGHONG PULIN FOOD PRODUCTS CO.,LTD."
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth for diagnostic performance is not relevant here.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A.
- 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: N/A. This is not an AI-assisted diagnostic device.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: N/A. This is not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A. The "ground truth" for this device relates to meeting physical specifications defined by the ASTM standard.
- 8. The sample size for the training set: N/A. This is not an AI/machine learning device.
- 9. How the ground truth for the training set was established: N/A.
In summary, this document describes a medical device (examination gloves) that meets industry standards for physical properties and biocompatibility, as required for its regulatory clearance. It does not involve AI, diagnostic performance, or extensive clinical study designs as typically outlined for software as a medical device (SaMD) or AI-enabled diagnostic tools.
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TANGSHAN ZHONGHONG PULIN FOOD PRODUCTS CO.,LTD.
LUANNAN,TANGSIIAN CITY,HEBEI PROVINCE,CHINA Tel: 86-315-4168379
Fax: 86-315-4168700
022091
510 (k) SUMMARY
- Submitter's name and address:
Baldur Systems Corporation
DEC 3 0 2002
33235 Transit Avenue
Union City,CA 94587
Telephone and Fax numbers of submitter:
Tel:510-477-9194
Fax:510-477-9634
David Hu,Ph.d.,president Contact person:
Date summary prepared: April 30,2002
-
- Common name: Exam gloves
Classification name: Patient examination glove
- Common name: Exam gloves
-
- Legally marketed device:
Class I vinyl patient examination gloves
- Legally marketed device:
80LYZ,powder-frce,that mects all the requirements
of ASTM D 5250-00.
- Description of the device:
Class I vinyl patient examination gloves 80LYZ,powder-free,that meets all the requirements of ASTM D 5250-00.
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TANGSHAN ZHONGHONG PULIN FOOD PRODUCTS CO.,LTD.
LUANNAN,TANGSHAN CITY,HEBEI PROVINCE,CHINA
Tel: 86-315-4168379 Fax: 86-315-4168700
- Intended use of device:
A patient examination glove is a disposable
Device,intended for medical purpose that
is worn on the examiner's hand or finger to
prevent contamination between patient and
cxaminer.
6a)Technological characteristics compared to ASTM standard
D 5250 - 00:
Dimension and tolerance (S-2,AQL 4.0)
| S | M | L | XL | Tolerance | |
|---|---|---|---|---|---|
| Width | 85 | 95 | 105 | 115 | $\pm$ 5 (ASTM D 5250) |
| 85 | 95 | 105 | 115 | $\pm$ 3 (ZHONGHONG) | |
| Length | 230 | 230 | 230 | 230 | min (ASTM D 5250) |
| 230 | 230 | 230 | 230 | min (ZHONGHONG) |
Biocompatability data arc conducted on the polymer coated vinyl gloves.
Physical requirements
Before and after accelerated aging 70±2 ℃ C for 72±2 hours,according to D573.(Inspection level S-2,AQL 4.0)
Tonsile strength (Mpa,min): 9.0
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.
Public Health Service
DEC 3 0 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Tangshan Zhonghong Pulin Food Products Company Limited C/O Dr. David Hu HTI Trading Group 33235 Transit Avenue Union City, California 94587
Re: K022091
Trade/Device Name: Vinyl Examination Gloves, Powder-Free Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: November 8, 2002 Received: December 9, 2002
Dear Dr. Hu:
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.
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Page 2 - Dr. Hu
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 (301) 594-4618. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page _ of
ко22091 510(k) Number (if known):
Vinyl Exam Gloves, Powder-free Device Name:_
Indications For Use
A Vinyl 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chin S. Lim
Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental De
510(k) Number: K022091
Prescription Use_ (Per 21 CFR 801 109) OR
Over-The-Counter Use __
(Oplional Formal 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.