(173 days)
Not Found
No
The device description and performance studies focus on the physical and barrier properties of a patient examination glove, with no mention of AI or ML technology.
No
A therapeutic device is used to treat or cure a disease or condition. This device is a glove for preventing contamination, not for treating any medical condition.
No
Explanation: The device is described as a patient examination glove, intended to prevent contamination between the patient and examiner by acting as a barrier. Its purpose is protective, not diagnostic.
No
The device description clearly states it is a physical product (gloves) and the testing described relates to physical properties and barrier function, not software.
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 patient and examiner by being worn on the hands or fingers. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description reinforces the function as a barrier.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing information about a patient's health status based on in vitro analysis.
- Testing: The testing described focuses on physical properties, barrier integrity, and biocompatibility, which are relevant to a physical barrier device, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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 (comma separated list FDA assigned to the subject device)
LYZ
Device Description
The subject device is Powder-Free Vinyl Patient Examination Gloves that is worn upon the examiner's hands or finger. As a barrier, the subject device prevents contamination between patient and examiner. The subject device meets all of the requirements of ASTM standards D5250-06 for Physical and performance characteristics, D5151-06 for barrier properties and D6124-06 for residual powder.
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 / medical purposes
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)
Non-clinical tests were conducted on the subject device.
The dimensions and physical properties tests followed ASTM D5250-06 and met AQL 2.5, inspection level S-2.
The barrier test followed ASTM D5151-06 and met AQL 2.5, inspection level S-1. Residual powder test followed ASTM D6124 and met the requirement of powder-free glove.
Biocompatibility test followed ISO 10993-10 showing no primary skin irritation or sensitization, under the conditions of study.
The subject device met the requirements of non-clinical tests, and performed similar to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 25, 2015
Shenyi Shandong Plastic Products, Co. Ltd. C/O Mr. Ray Zhou Official Correspondent Basic Medical Industries, Inc. 12390 East End Ave. Chino, CA 91710
Re: K142892
Trade/Device Name: Powder-Free Clear Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: February 13, 2015 Received: February 23, 2015
Dear Mr. Zhou:
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.
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Page 2 - Mr. Zhou
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 device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K142892
Device Name
Powder-free Clear Vinyl Patient Examination Gloves
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)
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:
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510(k) Summary
Submitter's Name and Address:
Shenyi (Shandong) Plastic Products, Co. Ltd. No.23 Fenghuang Road Fengshan Industry Park Linzi Shandong, 255400 China
Contact Person:
Minghao Shi, Marketing Manager Phone: # 86-533 7527018
Date Summary prepared: March 19, 2015
Name of the Device:
Powder-free Clear Vinyl Patient Examination Gloves
Assigned 510(k) Number
Common name/classification name of the Device:
Patient Examination Glove Device Class: Class I Regulation number: 21 CFR 880.6250 Product code: LYZ
Predicate Device Information:
Device name: Vinyl Examination Gloves, Powder-Free 510(K) #: K022091 Manufacturer name: Tangshan Zhonghong Pulin Food Products Co., Ltd
Device Description:
The subject device is Powder-Free Vinyl Patient Examination Gloves that is worn upon the examiner's hands or finger. As a barrier, the subject device prevents contamination between patient and examiner. The subject device meets all of the requirements of ASTM standards D5250-06 for Physical and performance characteristics, D5151-06 for barrier properties and D6124-06 for residual powder.
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Indications for Use:
The subject device is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner.
Comparison to Predicate Devices:
Powder-free Clear Vinyl Patient Examination Gloves (K142892) is substantially equivalent to the Vinyl Examination Gloves, Powder-Free (K022091).
| Proposed Device (K142892) | Predicate Device (K022091) | COMMENTS | |
|---|---|---|---|
| The device | Shenyi (Shandong) Plastic | ||
| Products, Co. Ltd. Powder- | |||
| free Clear Vinyl Patient | |||
| Examination Gloves | Vinyl Examination Gloves, | ||
| Powder-Free Tangshan | |||
| Zhonghong Pulin Food | |||
| Products Co., Ltd | |||
| Regulation # | 21 CFR 880.6250 | 21 CFR 880.6250 | Substantially |
| equivalent | |||
| Device Class | Class I | Class I | Substantially |
| equivalent | |||
| Product Code: | LYZ | LYZ | Substantially |
| equivalent | |||
| Indications for | |||
| Use | Disposable device intended for | ||
| medical purposes that is worn | |||
| on the examiner's hand or | |||
| finger to prevent | |||
| contamination between patient | |||
| and examiner | Disposable device intended | ||
| for medical purposes that is | |||
| worn on the examiner's hand | |||
| or finger to prevent | |||
| contamination between | |||
| patient and examiner | Substantially | ||
| equivalent | |||
| 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. | Substantially | ||
| equivalent | |||
| Device Materials | Poly Vinyl Chloride | Poly Vinyl Chloride | Substantially |
| equivalent | |||
| Residual Powder |