(214 days)
Not Found
No
The device description and performance studies focus on physical properties and barrier function, with no mention of AI or ML.
No.
The device acts as a barrier to prevent contamination, which is a prophylactic function, not a therapeutic one that treats or cures a condition.
No
The device is a patient examination glove, which functions as a barrier to prevent contamination, not to diagnose a condition or disease.
No
The device is a physical examination glove, which is a hardware device, not software. The description details physical properties and performance tests related to the material and structure of the glove.
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 "disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner." This describes a barrier device for personal protection and infection control, not a device used to examine specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or condition.
- Device Description: The description focuses on physical properties like dimensions, thickness, tensile strength, and elongation, which are relevant to the barrier function of a glove. It does not mention any components or functions related to analyzing biological samples.
- Regulation Number and Product Code: The regulation number (21 CFR 880.6250) and product code (LYZ) are specifically for "Patient Examination Glove," which falls under the category of general hospital and personal use devices, not IVDs.
- Performance Studies: The performance studies described focus on physical properties, barrier integrity (pinhole test), and biocompatibility, all of which are relevant to the function of a protective glove. There are no studies related to the analysis of biological samples or diagnostic performance metrics like sensitivity or specificity in a diagnostic context.
In summary, the device's intended use, description, regulatory classification, and performance testing all indicate that it is a medical device used for barrier protection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.
Product codes
LYZ
Device Description
Subject device: Vinyl Exam Gloves, Powder Free, Clear Device Class: Class I Regulation number: 21 CFR 880.6250 Product code: LYZ Length: 230 mm min Width: 94 mm min Palm Thickness: 0.09 mm min Fingertip Thickness: 0.085 mm min
Tensile Strength (Mpa) Before aging 16.96Mpa average After aging 14.92Mpa average
Ultimate Elongations Before aging 519% average After aging 480% average
Device functions: As a barrier, the subject device prevents contamination between patient and examiner
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands or fingers
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
The standards used for Zibo Hongchin Plastic and Rubber Co.,Ltd glove production are based on ASTM-D-5250-06. All testing meets requirements for dimensions, physical properties, barrier properties and powder under ASTM-D-5250-06. Physical property test conducted on gloves meets Inspection Level S-2, AQL 2.5.
The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, Inspection Level I, meeting these requirements.
Biocompatibility test results showing no primary skin irritation or sensitization under the conditions of study.
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.
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Image /page/0/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" arranged around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing right, with flowing lines that could be interpreted as hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 19, 2016
Zibo Hongchin Plastic and Rubber Co., Ltd % Ms. Sophie Hao Official Correspondent Basic Medical Industries, Inc. 805 Barrington Ave Ontario, CA 91764
Re: K161390
Trade/Device Name: Vinyl Exam Gloves, Powder Free, Clear Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: November 2, 2016 Received: November 10, 2016
Dear Ms. Hao:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Ryan -S
for Tina Kiang, PhD Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control. and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) KIJ1390
Device Name
Vihyl Exam Gloves, Powder Free, Clear
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
2 Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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510 (K) SUMMARY
1. Submitter's Identification:
Zibo Hongchin Plastic and Rubber Co.,Ltd No 17 Yingxiong Rd, Zhangdian District, Zibo Shandong, 255400 China
Date summary prepared: December 8, 2016
2. Name of the Device:
Zibo Hongchin Plastic and Rubber Co.,Ltd Vinyl Exam Gloves, Powder Free, Clear
3. Common name/classification name of the Device: Patient Examination Gloves Device Class: Class I Regulation number: 21 CFR 880.6250 Product code: LYZ
4. Contact Person:
James Ren, Product Manager Phone: # 86-1378989666 Zibo Hongchin Plastic and Rubber Co.,Ltd No 17 Yingxiong Rd, Zhangdian District, Zibo Shandong, 255400 China
Predicate Device Information: ક.
Device name: Vinyl Examination Gloves Powder-Free 510(K) #: K022091 Manufacturer name: Tangshan Zhonghong Pulin Food Products Co., Ltd
6. Device Description:
Subject device: Vinyl Exam Gloves, Powder Free, Clear Device Class: Class I Regulation number: 21 CFR 880.6250 Product code: LYZ Length: 230 mm min Width: 94 mm min Palm Thickness: 0.09 mm min Fingertip Thickness: 0.085 mm min
Tensile Strength (Mpa) Before aging 16.96Mpa average After aging 14.92Mpa average
4
Ultimate Elongations Before aging 519% average After aging 480% average
Device functions: As a barrier, the subject device prevents contamination between patient and examiner
7. Indication for Use:
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner
8. Comparison to Predicate Devices:
Zibo Hongchin Plastic and Rubber Co., Ltd Vinyl Exam Gloves, Powder Free, Clear are substantially equivalent in safety and effectiveness to the Zhonghong Pulin Food Products Co., Ltd Vinyl Examination Gloves, Powder-Free. (K022091)
| Proposed Device | Predicate Device (K022091) | COMMENTS | |
|---|---|---|---|
| The device | Zibo Hongchin Plastic and | ||
| Rubber Co.,Ltd Vinyl Exam | |||
| Gloves, Powder Free, Clear | Vinyl Examination Gloves, | ||
| Powder-Free Tangshan | |||
| Zhonghong Pulin Food | |||
| Products Co., Ltd | |||
| Regulation # | 21 CFR 880.6250 | 21 CFR 880.6250 | Similar |
| Device Class | Class I | Class I | Similar |
| Product Code: | LYZ | LYZ | Similar |
| Indications for | |||
| Use | A patient examination glove is | ||
| a disposable device intended | |||
| for medical purposes that is | |||
| worn upon the examiner's | |||
| hands or fingers to prevent | |||
| contamination between patient | |||
| and examiner | A patient examination glove | ||
| is a disposable device | |||
| intended for medical | |||
| purposes that is worn upon | |||
| the examiner's hands or | |||
| fingers to prevent | |||
| contamination between | |||
| patient and examiner | Similar | ||
| Basic Design | Cover the hand and wrist area. | ||
| Clovers have separate sheaths | |||
| or openings for each finger | |||
| and the thumb. | Cover the hand and wrist | ||
| area. Clovers have separate | |||
| sheaths or openings for each | |||
| finger and the thumb. | Similar | ||
| Device Materials | Poly Vinyl Chloride | Poly Vinyl Chloride | Similar |
| Residual Powder |