(78 days)
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.
Class 1 vinyl patient examination glove 80LYZ, powder-free, that meets all the requirements of ASTM D 5250 - 92.
This submission is for a medical device called "GG" vinyl examination gloves, powder-free, which falls under the classification of Patient examination glove (per 21 CFR 880.6250). The device is intended for medical purposes as a disposable item worn on the examiner's hand or finger to prevent contamination between the patient and examiner.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the "GG" vinyl examination gloves, powder-free, are based on the ASTM standard D 5250 - 92, and FDA pinhole requirements. The document indicates that the device's performance "meets or exceeds the ASTM or equivalent standard" and "meets FDA pinhole requirements."
| Acceptance Criteria (Based on ASTM D 5250 - 92 and FDA Pinhole Requirements) | Reported Device Performance |
|---|---|
| Dimension and Tolerance (Inspection level S-2, AQL 4.0) | Meets/Exceeds ASTM D 5250 |
| * Width (S, M, L, XL sizes) | Meets/Exceeds ASTM D 5250 |
| * Length (All sizes) | Meets/Exceeds ASTM D 5250 |
| Physical Requirements (Before and after accelerated aging 70 + 2 C for 72 + 2 hours, according to D573. Inspection level S-2, AQL 4.0) | Meets/Exceeds ASTM D 5250 |
| * Tensile strength (Mpa, min) | 9.0 (Minimum required 9.0) |
| * Ultimate Elongation (%, min) | 300 (Minimum required 300) |
| Pinhole Requirements | Meets FDA pinhole requirements |
Note on "Reported Device Performance": The provided text explicitly states that the gloves "meet or exceed the ASTM or equivalent standard" and "meet FDA pinhole requirements." For specific numerical criteria like tensile strength and ultimate elongation, the document lists the reported values as 9.0 Mpa (min) and 300% (min) respectively, which directly match the minimum requirements. For dimension and tolerance, the table simply states "Meets/Exceeds ASTM D 5250" as specific measured values for each size are not provided, only the general standard of compliance.
2. Sample Size and Data Provenance
The document does not explicitly state the sample size used for the test set in the same way clinical trials report them. Instead, it refers to "Inspection level S-2, AQL 4.0" for both dimension and tolerance and physical requirements. These are sampling plans specified in quality control standards (like ISO 2859-1 or MIL-STD-105E, of which AQL is a part) for attribute sampling.
- Sample Size for Test Set: Not explicitly stated as a number of devices/gloves. It refers to "Inspection level S-2, AQL 4.0," which defines a sampling plan from which sample sizes are derived based on batch size. The specific sample size for a given batch size would need to be looked up in the relevant AQL tables.
- Data Provenance: The data is generated from the manufacturer in Taiwan, R.O.C. (General Gloves Corp., No. 25, Pei Ma, 1 6 Lin, Tung Chung Village, Tung Shan Hsiang, Tainan Hsien, Taiwan 733). The data appears to be prospective as it involves performance testing of the manufactured product against established standards.
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable in the context of this device. The ground truth for examination gloves is based on established engineering and material standards (like ASTM D 5250 - 92) and regulatory requirements (like FDA pinhole requirements), not on expert consensus or interpretation of medical images. The "experts" are the engineers and quality control personnel performing the tests according to the standard operating procedures derived from ASTM.
4. Adjudication Method for the Test Set
This is not applicable for this type of device testing. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or image-based diagnostic studies where there's subjectivity and potential for disagreement among human readers or interpreters. For physical and dimensional testing of gloves against a standard, the results are typically quantitative measurements or pass/fail criteria based on objective methods.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable. An MRMC study assesses the effectiveness of human readers (e.g., radiologists) with and without AI assistance in diagnostic tasks. Since this device is a physical examination glove, there are no "human readers" in a diagnostic context, and therefore, no AI assistance to compare.
6. Standalone (Algorithm Only) Performance
This is not applicable. This device is a physical product (gloves), not an algorithm or software. Therefore, there is no "standalone algorithm" performance to report.
7. Type of Ground Truth Used
The ground truth for the device's performance is based on established engineering standards and regulatory requirements. Specifically:
- ASTM D 5250 - 92: This standard defines the requirements for dimensions, tensile strength, and ultimate elongation for vinyl patient examination gloves.
- FDA Pinhole Requirements: These are regulatory standards for the barrier integrity of examination gloves.
8. Sample Size for the Training Set
This is not applicable. The concept of a "training set" and "test set" in the context of machine learning or AI is not relevant to the evaluation of a physical product like examination gloves. The manufacturing process of gloves does not involve machine learning models that are "trained."
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reasons as #8. There is no training set in the context of this device's regulatory submission.
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Image /page/0/Picture/0 description: The image shows the logo for General Gloves Corp. The logo includes the company name in bold, black letters, with the first letter "G" stylized and enlarged. Above the company name, the text "NOV 6 1998" is visible, likely indicating a date. Below the company name, there is text in a different language, possibly Chinese, which translates to "General Gloves International Co., Ltd."
ei Ma 16 Lin Tung Chung Village Tung Shan Hsiang. Tainan Hsien. Taiwan 73
No. 25, Pei Ma, 1 6 Lin, Tung Chung Village, Tung Shan Hsiang, Tainan Hsien, Taiwan 733, R. O. C.
982933
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:
Tel: 510-732-9623 Fax: 510-732-9716
Contact person: David Hu, Ph.D., President
Date summary prepared: September 23, 1998
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Image /page/1/Picture/0 description: The image shows a logo with two overlapping letters, 'G' and 'G', with the letters in different styles. The first 'G' is outlined in black, while the second 'G' is filled in with black. To the right of the letters, there is a small 'TM' symbol, indicating a trademark.
GENERAL 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.
| 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, powder-free, that meets all the requirements of ASTM D 5250 - 92. | |||||||
| 4). Description of the device: Class 1 vinyl patient examination glove 80LYZ, powder-free, 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 | 8587 | 9597 | 105107 | 115117 | +5+3 | ASTM D 5250(General) | |
| length | 230230 | 230230 | 230230 | 230230 | min.min. | ASTM D 5250(General) |
Biocompatability data are conducted on the polymer coated vinyl gloves.
.
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Image /page/2/Picture/0 description: The image shows the logo for General Gloves Corp. The logo features a stylized "G" and the company name in bold, black letters. Below the company name is the Chinese translation of the company name, "通用手套國際股份有限公司". There is also a handwritten number "K982933".
No. 25, Pei Ma, 1 6 Lin, Tung Chung Village, Tung Shan Hsiang, Tainan Hsien, 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)
Tensil strength (Mpa, min) Ultimate Elongation (%, 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 qloves meet the labeling claims as shown by the data in (a) (6) .
.
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare. The symbol is composed of three curved lines that converge at the bottom, creating a sense of movement or flow.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 1998 NOV
General Gloves Corporation C/O David Hu, Ph.D., President Sponsors's Representative HTI Trading Group 3423 Investment Boulevard, Suite 12 Hayward, California 94545-3822
Re: K982933 Vinyl Examination Gloves, Powder-Free Trade Name: Regulatory Class: I Product Code: LYZ October 26, 1998 Dated: Received: October 29, 1998
Dear Dr. 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 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). 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. ਸ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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
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Page 2 - Dr. Hu
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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" (21CFR 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/dsma/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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Page Page of
K982933 510(k) Number (if known): Patient examination glove Device Name:
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Jise Over-The-Counter Use (Per 21 CFR 801.109) (Division Sign-Off) (Optional Format 1-2-96) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.