(78 days)
K#960746, K#974151
K#960746, K#974151
No
The device description and performance studies focus on the physical properties and safety of a patient examination glove, with no mention of AI or ML technology.
No
A patient examination glove is intended to prevent contamination, not to provide therapy or treatment to a patient.
No
Explanation: The provided text explicitly states that the device is a "patient examination glove" and describes its purpose as preventing contamination. There is no mention of it being used to diagnose conditions or processes.
No
The device description clearly identifies the device as a physical patient examination glove, which is a hardware component.
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 barrier device for physical protection, not a device used to examine specimens in vitro (outside the body) to diagnose or monitor a condition.
- Device Description: The description classifies it as a "Powdered Vinyl Patient Examination Glove" under a specific FDA regulation (21 CFR 880.6250) related to general and plastic surgery devices. IVD devices fall under different regulatory classifications.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing diagnostic information about a patient's health status
- Using reagents or analytical methods
The device's purpose is to provide a physical barrier during patient examination, which is a different function than an in vitro diagnostic test.
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 and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is 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
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
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare and similar personnel, 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)
The standards used for Shijiazhuang Hongxiang Plastics Products Co., Ltd. glove production are based on ASTM-D-5250-92. All testing meets requirements for Physical and 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
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
NOV - 5 1999
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is:
1. Submitter's Identification:
Ms. Guixi Liu Shijiazhuang Hongxiang Plastics Products Co., Ltd. Lu Quan City, New High Technologies Industrial Zone Shijaizhuang, Hebei Province P.R. China
Date Summary Prepared: July 29, 1999
Name of the Device: 2. -
Shijiazhuang Hongxiang Plastics Products Co., Ltd. Synthetic 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 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.
5. Intended Use:
A patient examination glove is a disposable device intended for medical purposes that 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.
1
6. Comparison to Predicate Devices:
Shijiazhuang Hongxiang Plastics Products Co., Ltd. Synthetic Powdered Vinyl Patient Examination Gloves, is substantially equivalent in safety and effectiveness to the Sunmax Enterprise Shanghai Co., Ltd. Powdered Vinyl Patient Examination Gloves and the Shanghai Super Gloves Company, Ltd. Powder Vinyl Patient Examination Gloves.
Discussion of Non-Clinical tests Performed for Determination of Substantial 7. Equivalence are as follows:
The standards used for Shijiazhuang Hongxiang Plastics Products Co., Ltd. glove production are based on ASTM-D-5250-92. All testing meets requirements for Physical and 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 gloves as hypoallergenic on our labels.
Discussion of Clinical Tests Performed: 8.
Not Applicable - There is no hypoallergenic Claim.
9. Conclusions:
Shijiazhuang Hongxiang Plastics Co., Ltd. Synthetic Vinyl Patient Examination gloves (Powdered) conform fully to ASTM-D-5250-92 standard as well as applicable 21 CFR references, and, meets pinhole 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/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 a stylized image of three birds in flight, arranged in a stacked formation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 5 1999
Shijiazhuang Hongxiang Plastics Products Co., Ltd. c/o Ms. Karen Abell Official Correspondent for Shijiazhuang Hongxiang Plastics Products Co., Ltd. Basic Medical Industries, Inc. 12390 East End Avenue Chino, California 91710
Re : K992797 Synthetic Powdered Vinyl Patient Examination Trade Name: Gloves Regulatory Class: I . . . . Product Code: LYZ Dated: July 29, 1999 Received: August 19, 1999
Dear Ms. Abell:
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 aqainst 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 requlations 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) requlation (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
3
Page 2 - Ms. Abell
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 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" (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,
Kilitaturski
Timothy A. Ulatowski
thy 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
(IF KNOWN) : _ 510(k) NUMBER
Shijiazhuang Hongxiang Plastics Products Co., Ltd. DEVICE NAME: INDICATIONS FOR USE: Synthetic Powdered Vinyl Patient Examination Gloves-Powdered
A patient examination glove is 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.)
| Concurrent of CDRH, Office of Device Evaluation (ODE) |
|---|
| ------------------------------------------------------- |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter-Use |
|---|---|---|
| (Optional Format 1-2-96) |
| (Division Sign-Off) |
|---|
| --------------------- |
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | K992797 |
|---|---|
| --------------- | --------- |