(49 days)
K#960746, K#974151
K#960746,K#974151
No
The device is a patient examination glove, and the description focuses on material properties, testing standards, and intended use for preventing contamination. There is no mention of AI or ML capabilities.
No
Explanation: The device, a patient examination glove, is intended to prevent contamination and is not designed for therapeutic purposes such as treating or alleviating a disease or condition.
No
Explanation: The device is a patient examination glove, intended for preventing contamination, not for diagnosing medical conditions.
No
The device is a physical patient examination glove, not a software application.
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 device is a "patient examination glove" worn on the hand to prevent contamination between healthcare personnel and the patient. This is a physical barrier function, not a diagnostic test performed on a sample from the body.
- Device Description: The description classifies it as a "Patient Examination Glove" under 21 CFR 880.6250, which falls under the General and Plastic Surgery Device Panel. IVDs are typically regulated under different sections of the CFR related to clinical chemistry, immunology, microbiology, etc.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Detecting or measuring a substance in a sample
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of a sample.
- Performance Studies: The performance studies focus on physical properties (dimensions, water fill test) and biocompatibility (skin irritation, sensitization), which are relevant for a physical barrier device, not an IVD.
In summary, the device's function is to provide a physical barrier for infection control, not to perform a diagnostic test on a biological sample.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare similar personnel to prevent contamination between and 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 A pation. Oxaminer's hand or finger to prevent contamination between patient and examiner.
Product codes
80LYZ
Device Description
Classified by FDA's General and Plastic Surgery Device Panel 21 CFR 880.6250, Powdered Vinyl Patient Class I, as 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 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)
Discussion of Non-Clinical Tests Performed for Determination 7. of Substantial Equivalence are as follows: standards used for Shijiazhuang Great Eagle Plastic The Products Co., Ltd. glove production are based on ASTM-D-5250-All testing meets requirements for Physical and 92. Dimensions Testing conducted on gloves, Inspection Level S-2, 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)
K#960746, K#974151
Reference Device(s)
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
DEC 4 1998
EXHIBIT #1 Page 1 of 2
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 §807.92.
The assigned 510(k) number is: 983645
1. Submitter's Identification:
Mr. Fanq Yi Liu Shijiazhuang Great Eagle Plastic Products Co., Ltd. 685 He Ping Road New Development Zone Shijiazhuang, He Bei Province P.R. China
Date Summary Prepared: October 14, 1998
2. Name of the Device:
Shijiazhuang Great Eagle Plastic Products Co., Ltd. Powdered Vinyl Patient Examination Gloves
3. Predicate Device Information:
Sunmax Enterprise Shanghai Co., Ltd. Powdered Vinyl Patient Examination Gloves, K#960746 Shanghai Super Gloves Company, Ltd. Powdered Vinyl Patient Examination Gloves, K#974151
4 . Device Description:
Classified by FDA's General and Plastic Surgery Device Panel 21 CFR 880.6250, Powdered Vinyl Patient Class I, as Examination Glove, 80LYZ, Powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.
5. Intended Use:
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare similar personnel to prevent contamination between and healthcare personnel and the patient's body, fluids, waste or environment.
1
EXHIBIT #1 Page 2 of 2
Comparison to Predicate Devices: 6.
Shijiazhuang Great Eagle Plastic Products Co., Ltd. Synthetic Powdered Vinyl Patient Examination Gloves, is substantially equivalent in safety and effectiveness to the Sunmax In Barcey and CricoloronesBal Vinyl Patient Enterprise Examination Gloves and the Shanghai Super Gloves Company, Ltd. Powdered Vinyl Patient Examination Gloves.
Discussion of Non-Clinical Tests Performed for Determination 7. of Substantial Equivalence are as follows:
standards used for Shijiazhuang Great Eagle Plastic The Products Co., Ltd. glove production are based on ASTM-D-5250-All testing meets requirements for Physical and 92. Dimensions Testing conducted on gloves, Inspection Level S-2, 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 qloves as hypoallergenic on our labels.
Discussion of Clinical Tests Performed: 8.
Not Applicable - There is no hypoallergenic claim.
9. Conclusions:
Shijiazhuang Great Eagle Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves (Powdered) conform fully to ASTM-D-5250-92 standards as well as applicable CFR 21 pinhole references, and, meets -FDA requirements, biocompatibility requirements and labeling claims as shown by data in Section 7. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is a symbol consisting of three stylized human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 1998 DEC
Shijiazhuang Great Eagle Plastics Products Company, Ltd. C/O Ms. Susan Goldstein-Falk Official Correspondent Basic Medical Industries, Incorporated 13945 Magnolia Avenue 91710 Chino, California
K983645 Re: Powdered Vinyl Patient Examination Gloves Trade Name: Requlatory Class: I Product Code: LYZ Dated: October 14, 1998 Received: October 16, 1998
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. ਉੱ 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 result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 requlations.
3
Page 2 - Ms. Goldstein-Falk
This letter will allow you to begin marketing your device as Inis icece described in your sie in promience of your device to a legally Finding of subscancedir equired in a classification for your marketed predicate awits 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 Compliance at (501) 331 ising 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 obtained from the brying (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdaggov/cdrh/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
thy A. Time 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): | |
|---|---|
| DEVICE NAME: | Shijiazhuang Great Eagle Plastics Products Co., Ltd. |
| Powdered Vinyl Patient Examination Gloves-Powdere | |
| INDICATIONS FOR USE: |
A patient examination glove is a disposable device intended for medical purposes that is A pation. Oxaminer's hand or finger to prevent contamination between patient and examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrent of CDRH, Office of Device Evaluation (ODE)
-The-Counter-Use X Prescription Use (Division Sign-Off (Optional Format 1-2-96) (Per 21 CFR 801.109) Division of Dental, Infection Control and General Hospital Devi 510(k) Number.