(96 days)
K# 983645
Not Found
No
The device is a patient examination glove, and the description focuses on material properties and performance standards, with no mention of AI or ML.
No
Explanation: The device is a patient examination glove intended to prevent contamination between healthcare personnel and patients, not to treat or diagnose a medical condition.
No
The description explicitly states its purpose is to prevent contamination, not to detect, monitor, or diagnose any medical condition. It is a barrier device.
No
The device description clearly identifies the device as a physical glove, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the glove is for preventing contamination between healthcare personnel and the patient's body, fluids, waste, or environment. This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The device is classified as a Class I medical device (21 CFR 880.6250, Powdered Vinyl Patient Examination Glove). IVDs typically fall under different classifications and regulations.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or provide diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on physical properties (dimensions, water fill test) and biocompatibility (skin irritation, sensitization), which are relevant for a barrier device, not an IVD.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This glove does not perform such a function.
N/A
Intended Use / Indications for Use
A glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
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
Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250, Powdered Vinyl Patient Examination Glove, 80LYZ, powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare and similar personnel
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)
The standards used for Shijiazhuang Great Eagle Plastics Products Co., Ltd. production are based on ASTM D5250-92. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-4, AQL 4.0.
The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, Inspection Level S-4, meeting these requirements. Primary Skin Irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K# 983645
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
SHIJIAZHUANG GREAT EAGLE PLASTICS PRODUCTS CO., LTD.
685 He Ping Road, New Development Zone, Shijiazhuang, Hebei Province 05003 1 P.R. China
NOV 2 9 1999
EXHIBIT #1
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 8807.92.
The assigned 510(k) number is:_K99.2862
Submitter's Identification: 1.
Mr. Fang Yi Liu Shijiazhuang Great Eagle Plastics Products Co., Ltd. 685 He Ping Road New Development Zone Shijiazhuang, Hebei Province 050031 P.R. China
Date Summary Prepared: August 1999
2. Name of the Device:
Shijiazhuang Great Eagle Plastics Products Co., Ltd.
Synthetic Powdered (Yellow) Vinyl Patient Examination Gloves-Powdered
3. Predicate Device Information:
Shijiazhuang Great Eagle Plastics Products Company, Ltd. Powdered Vinyl Patient Examination Gloves, K# 983645
4. Device Description:
Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250, Powdered Vinyl Patient Examination Glove, 80LYZ, powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.
1
SHIJIAZHUANG GREAT EAGLE PLASTICS PRODUCTS CO., LTD.
685 He Ping Road, New Development Zone, Shijiazhuang, Hebei Province 05003 1 P.R. China
ડ. Intended Use:
A glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Comparison to Predicate Devices: 6.
Shijiazhuang Great Eagle Plastics Products Co., Ltd. Synthetic Powdered (Yellow) Vinyl Patient Examination Gloves is substantially equivalent in safety and effectiveness to the Shijiazhuang Great Eagle Plastics Products Co., Ltd. Powdered Vinyl Patient Examination Gloves.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
The standards used for Shijiazhuang Great Eagle Plastics Products Co., Ltd. production are based on ASTM D5250-92. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-4, AQL 4.0.
The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, Inspection Level S-4, meeting these requirements. Primary Skin Irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.
There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels.
Shijiazhuang Great Eagle Plastics Products Co., Ltd., operates in compliance with FDA's GMP's.
Discussion of Clinical Tests Performed: 8.
Not Applicable - There is not hypoallergenic claim.
9. Conclusions:
Shijiazhuang Great Eagle Plastics Products Co., Ltd. Synthetic Powdered (Yellow) Vinyl Patient Examination Gloves conform fully to ASTM D5250-92 standards as well as applicable 21 CFR references, and meets pinhole FDA requirements, bio-compatibility requirements and labeling claims as shown by data submitted to FDA. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned within a circular border. Encircling the bird and following the curve of the circle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 9 1999
Ms. Susan D. Goldstein-Falk Official Correspondent for Shijiazhuang Great Eagle Plastics Products Company, Limited 685 He Ping Road, New Development Zone Shijiazhuanq, Hebei Province 050031 P.R. China
Re : K992862 Powdered Vinyl Patient Examination Gloves Trade Name: (Yellow) Regulatory Class: I Product Code: LYZ November 3, 1999 Dated: November 5, 1999 Received:
Dear Ms. Goldstein-Falk:
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 The general controls provisions of the Act 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. ਬੈ 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in
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Page 2 - Ms. Goldstein-Falk
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.
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 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 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
4
Attachment A
Page 1 of 1
| 510(k) Number (if known): | K99 2862 |
|---|---|
| DEVICE NAME: | Shijiazhuang Great Eagle Plastics Products Co., Ltd. |
| INDICATIONS FOR USE: | Synthetic Powdered (Yellow) Vinyl Patient Examination Gloves-Powdered |
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _X (Optional Format 1-2-96)
Ab In Clin.
Division of Dental, Infection Control, Cal Hoanits 510(k) Number