(16 days)
Not Found
No
The device is a patient examination glove, and the description focuses on material properties, testing standards, and intended use, with no mention of AI or ML.
No.
The device is a patient examination glove, intended to prevent contamination, not to treat or diagnose a disease or condition.
No
Explanation: The device description clearly states "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." Its purpose is to prevent contamination, not to diagnose medical conditions or diseases.
No
The device is a physical patient examination glove, which is a hardware device, not software. The description clearly outlines physical testing and material standards.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for preventing contamination between healthcare personnel and the patient's body, fluids, waste, or environment. This is a barrier function, not a diagnostic one.
- Device Description: It's classified as a Class I device by the FDA's General and Plastic Surgery Device panel, not an IVD panel.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (like blood, urine, or tissue) to diagnose a condition, monitor a disease, or screen for a health issue.
- Performance Studies: The performance studies focus on physical properties (dimensions, water fill test), skin reactions, and residual powder, which are relevant to a barrier device, not a diagnostic one.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This patient examination glove does not perform any such testing.
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
LYZ
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 D5250-00.
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
The standards used for Shijiazhuang Eversharp Plastics Products Co., Ltd. glove production are based on ASTM-D-5250-00. 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 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
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
MAY - 9 2003
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: K O31293
1. Submitter's Identification:
Mr. Yinhai Wang Shijiazhuang Eversharp Plastics Products Co., Ltd. No. 312 East Long Quan Road Luquan City, Hebei Province P.R. China
Date Summary Prepared: April 16, 2003
2. Name of the Device:
Shijiazhuang Eversharp Plastics Products Co., Ltd. Synthetic (White) Vinyl Patient Examination Gloves-Powder Free
3. Predicate Device Information:
Shijiazhuang Great Eagle Plastic Products Co., Ltd. Synthetic Powder Free (White) Vinyl Patient Examination Gloves (K000071)
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 D5250-00.
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 Eversharp Plastics Products Co., Ltd. Synthetic (White) Vinyl Patient Examination Gloves-Powder Free, is substantially equivalent in safety and effectiveness to the Shijiazhuang Great Eagle Plastic Products Co., Ltd. Synthetic Powder Free (White) Vinyl Patient Examination Gloves.
7. Discussion of Non-Clinical tests Performed for Determination of Substantial Equivalence are as follows:
The standards used for Shijiazhuang Eversharp Plastics Products Co., Ltd. glove production are based on ASTM-D-5250-00. 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 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 Eversharp Plastics Co., Ltd. Synthetic (White) Vinyl Patient Examination gloves-Powder Free 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/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 9 2003
Shijiazhuang Eversharp Plastics Products Co., Ltd. C/O Mr. James Chu Official Correspondent Gloveco, Incorporated 590 West Central Avenue, #D Brea, California 92821
Re: K031293
Trade/Device Name: Sythetic (White) Vinyl Patient Examination Gloves-Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: April 21, 2003 Received: April 24, 2003
Dear Mr. Chu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Chu
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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 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), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807,97). You may obtain other general information on your responsibilities under the Act from the Division 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/dsma/dsmamain.html
Sincerely yours,
Suser Rumpe
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment A
Page 1 of 1
510(k) NUMBER (IF KNOWN) : K Q312 93 Shijiazhuang Eversharp Plastics Products Co., Ltd. DEVICE NAME: INDICATIONS FOR USE: Synthetic (White) Vinyl Patient Examination Gloves-Powder Free
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.
(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 Anesthesiology, General Hospital,
Infection Control, Dental Devices
| 510(k) Number: | K031293 |
|---|---|
| ---------------- | --------- |