(62 days)
Not Found
Not Found
No
The device description and intended use clearly define a standard patient examination glove, with no mention of AI/ML or related technologies. The performance studies focus on material standards and pinhole requirements, not algorithmic performance.
No
A patient examination glove is intended to prevent contamination, not to treat a disease or condition.
No
The device is a patient examination glove, whose intended use is to prevent contamination between patient and examiner, not to diagnose a condition.
No
The device is a physical patient examination glove, which is a hardware device, 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 or finger. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a patient examination glove, which is a physical barrier.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information about a patient's health status.
IVD devices are designed to perform tests on samples from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
A 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.
Product codes (comma separated list FDA assigned to the subject device)
LYZ
Device Description
Class 1 vinyl patient examination glove 80LYZ, powdered, that meets all the requirements of ASTM D 5250 - 92.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Physical requirements: Before and after accelerated aging 70 + 2 C for 72 + 2 hours, according to D573. (Inspection level S-2, AQL 4.0).
- Biocompatibility data are conducted on the powdered vinyl gloves.
- Our gloves meet or exceed the ASTM or equivalent standard. Our gloves meet FDA pinhole requirements.
- Our gloves meet the labeling claims as shown by the data in (a) (6).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Ultimate Elongation (%, min) 300
Tensil strength (Mpa, min) 9.0
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
TM ERAL GLOVES CORP.
通用手套國際股份有限公司
No. 25, Pei Ma, 1 6 Lin, Tung Chung Village, Tung Shan Hsiang, Tainan Hsien, Taiwan 733, R. O. C.
510 (k) SUMMARY) [As required by §807.92(c)]
Submitter's name and address: HTI Trading Group 1) . 3423 Investment Blvd. Suite 12 Hayward, CA 94545
Telephone and Fax numbers of submitter:
510-732-9623 Tel: Fax: 510-732-9716
AUG 2 3 1999
David Hu, Ph.D., President Contact person:
Date summary prepared: June 21, 1999
1
GENERAL GLOVES CORP.
通用手套國際股份有限公司
T M
No. 25, Pei Ma, 1 6 Lin, Tung Chung Village, Tung Shan Hsian, Taiwan 733, R. O. C.
| 2). | Trade name: "G G" vinyl examination gloves powder-free | ||||||
|---|---|---|---|---|---|---|---|
| Common name: Exam gloves | |||||||
| Classification name: Patient examination glove | |||||||
| (per 21 CFR 880.6250) | |||||||
| 3). | Legally marketed device: Class I vinyl patient examination glove 80LYZ, powdered, that meets all the requirements of ASTM D 5250 - 92. | ||||||
| 4). | Description of the device: Class 1 vinyl patient examination glove 80LYZ, powdered, that meets all the requirements of ASTM D 5250 - 92. | ||||||
| 5). | Intended use of device: A 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. | ||||||
| 6a). | Technological characteristics compared to ASTM standard D 5250 - 92: | ||||||
| Dimension and tolerance (S-2, AQL 4.0) | |||||||
| S | M | L | XL | Tolerance | |||
| width | 85 | ||||||
| 87 | 95 | ||||||
| 97 | 105 | ||||||
| 107 | 115 | ||||||
| 117 | +5 | ||||||
| +3 | ASTM D 5250 | ||||||
| (General) |
230 230 length 230 230 min. ASTM D 5250 230 230 230 230 min. (General)
Biocompatability data are conducted on the powdered vinyl gloves .
2
ERAL GLOVES CORP.
通用手套國際股份有限公司
No. 25, Pei Ma, 1 6 Lin, Tung Chung Village, Tung Shan Hsian, Taiwan 733, R. O. C.
- Physical requirements 6a) .
Before and after accelerated aging 70 + 2 C for 72 + 2 hours, according to D573. (Inspection level S-2, AQL 4.0)
Ultimate Elongation (%, min) Tensil strength (Mpa, min) 300 9.0
-
Assessment of performance data (non-clinical tests): 6b(1) . .
The performance test data is the same as for 807.92(a)96) mentioned immediately above. -
Assessment of performance data (clinical tests) : 6b(2) . Not required.
-
Our gloves meet or exceed the ASTM or equivalent standard. 6b(3) . Our gloves meet FDA pinhole requirements.
Our gloves meet the labeling claims as shown by the data in (a) (6) .
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 3 1999
General Gloves Corporation C/O Mr. David Hu, Ph.D. President HTI trading Group 3423 Investment Boulevard # 12 Hayward, California 94545
Re : K992107 Baldur Brand Vinyl Powdered Examination Gloves Trade Name: Requlatory Class: I Product Code: LYZ Dated: June 21, 1999 Received: July 01, 1999
Dear Mr. Hu:
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 Regulations, 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 successful in regulatory action. In addition, FDA may publish further 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.
4
Page 2 - Mr. Hu
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 Ehus, 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 Additionally, for questions on the promotion and (301) 594-4692. 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 Other general information on your responsibilities CFR 807.97). 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy Ulatowsk Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
GENERAL GLOVES CORP.
通用手套國際股份有限公司
No. 25, Pei Ma, 16 Lin, Tung Chung Village, Tung Shan Hsian, Taiwan 733, R. O. C.
STATEMENT OF INDICATIONS FOR USE [807.92(a) (5) ] .
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 MOX WRITERBELOM:THIS-LINE-CONTINUE-ON-ANGTHER®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
Olin S. Lin
on Sign-Off) sion of Dental, Inte i General Ho 510(k) Numb
T M