(57 days)
Not Found
No
The device description and performance studies focus on the physical properties and testing of a patient examination glove, with no mention of AI or ML.
No.
The device is described as a "patient examination glove" intended to "prevent contamination" between healthcare personnel and the patient. This is a barrier device for infection control, not a device used to treat a disease or medical condition.
No
Explanation: The device is a patient examination glove, intended to prevent contamination. Its purpose is not to diagnose or provide diagnostic information about a patient's condition.
No
The device description clearly identifies the device as a physical patient examination glove, a hardware product, and references physical testing standards. There is no mention of software components.
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 derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The classification is under "General and Plastic Surgery Device panel," specifically for "Powder-Free Vinyl Patient Examination Glove." This classification is not associated with IVD devices.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or any other elements typical of IVD devices.
Therefore, this device falls under the category of medical devices used for barrier protection, not in vitro diagnostics.
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 a purpose that is worn on the examiner'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 as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D-5250-00-4.
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 Hongxiang Plastics Products Co., Ltd glove production are based on ASTM-D- D-5250-00 4. 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 based on ASTM D5151-99 was also conducted with samplings of AQL 2.5, Inspection Level I, 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.
A residual Powder Test that based on ASTM-D6124-01 for Starch at finished inspection is conducted to insure that our gloves meet our "powder-free" claims (contain no more than 2 mg powder per glove).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
FEB 1 4 2006
EXHIBIT #1 Page 1 of 2 .
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:
Mr. Guixi Liu Shijiazhuang Hongxiang Plastic Products Co., Ltd. New High Technologies Industrial Zone Luquan City, Hebei, China
elimination
Date Summary Prepared: November 28, 2005
2. Name of the Device:
Shijiazhuang Great Eagle Plastic Products Co., Ltd. Powder Free Sterile Vinyl/Glove (Clear&Yellow)
3. Predicate Device Information:
Shijiazhuang Great Eagle Plastic Products Co., Ltd. Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves (K992861)
4. Device Description:
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D-5250-00-4.
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 Plastic Products Co., Ltd.'s Powder Free Sterile Vinyl Glove (Clear & Yellow) is substantially equivalent in safety and effectiveness to the Shijiazhuang Great Eagle Plastic Products Co., Ltd., Syntheric Powder Free (Yellow) Vinyl Patient Examination Gloves.
7. Discussion of Non-Clinical tests Performed for Determination of Substantial Equivalence are as follows:
The standards used for Shijiazhuang Hongxiang Plastics Products Co., Ltd glove production are based on ASTM-D- D-5250-00 4. 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 based on ASTM D5151-99 was also conducted with samplings of AQL 2.5, Inspection Level I, 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.
A residual Powder Test that based on ASTM-D6124-01 for Starch at finished inspection is conducted to insure that our gloves meet our "powder-free" claims (contain no more than 2 mg powder per glove).
8. Discussion of Clinical Tests Performed:
Not Applicable - There is no hypoallergenic claim.
9. Conclusions:
Shijiazhuang Hongxiang Plstic Products Co., Ltd.'s Powder Free Sterile Vinyl Glove (Clear& Yellow) conform fully to ASTM D-5250-00" 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/2 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized depiction of a human figure, with three abstract shapes representing the head, body, and legs. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" which is arranged in a circular pattern around the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 4 2006
SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO, LTD C/O Ms. Micky Lin Gloveco, Inc. 3973 Schaefer Ave. Chino, California 91710
Re: K053523
. K055523
Trade/Device Name: Powder Free Sterile Vinyl Glove (Clear and Yellow) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: Class I Product Code: 80LYZ Dated: January 30, 2006 Received: January 31, 2006
Dear Ms. Lin:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have to rowed young young determined the device is substantially equivalent (for the receiced above and nave aboute) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mensiale commerce prior to that have been reclassified in accordance with the provisions of Amendinents, or to actives that tic Act (Act) that do not require approval of a premarket the rederal I vou, Drag, and Commay, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provision 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Mr), it may be subject to back of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roundsh further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Lin
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA Sissuance of a saoomarks with other requirements
mean that FDA has made a determination that your device complies with of acception mean that I DA has made a deceminations administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by other major in of the Act of ally rederal statutes and regaraters, including, but not limited to: registration You must comply with an the Free Proq. 21 CFR Part 801); good manufacturing practice. and ifsung (21 CFR Tart 807), aboling (21 CFR (OS) regulation (21 CFR Part 820); and if requirements as set form in the quality byttens (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 5 10(k) This letter will anow you to objal finding of substantial equivalence of your device to a premits in the cation. THE PDF Intelling a 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), If you desire specific advice for Jour see at (240) 276-0115. Also, please note the regulation in prease contact the Other of Ochiphants and (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suttie Y. Michael DMD
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
ATTACHMENT A
INDICATION FOR USE
510 (k) NUMBER (IF KNOW): 上一篇55522
Shijiazhuang Hongxiang Plastic Prodcuts Co., Ltd. APPLICANT: Powder Free Sterile Vinyl Examination Glove (Clear & DEVICE NAME: Yellow)
INDICATIONS FOR USE:
A patient examination glove is disposable device intended for medical a purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Preseription Use (Per 21 CFR 801.109) ()[{{
Over-The-Counter-Use
(Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrent of CDRH, Office of Device Evaluation (ODE)
| Shala A. Murphy | |
|---|---|
| 2/14/04 |
Division of Anesthesiology, General Hospital,
Master Control, Dental Devices
| K053523 | |
|---|---|
| -- | --------- |