(161 days)
Not Found
No
The device description and performance studies focus solely on the physical properties and biocompatibility of a standard patient examination glove, with no mention of AI or ML technologies.
No
The device, a patient examination glove, is intended to prevent contamination between patient and examiner, not to treat or cure a disease or condition.
No
Explanation: The device is a patient examination glove, intended to prevent contamination. It does not perform any diagnosis or provide diagnostic information.
No
The device description clearly states it is a physical glove made of vinyl, intended to be worn on the hands or fingers. It describes physical properties and testing related to the material and construction of the glove, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "worn upon the examiner's hands or fingers to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description reinforces the barrier function and mentions testing related to the physical properties of the glove (powder content, pinholes, tensile strength, biocompatibility). None of these relate to analyzing biological samples for diagnostic purposes.
- Lack of IVD Characteristics: An IVD device would typically involve:
- Analyzing a sample from the human body (blood, urine, tissue, etc.).
- Providing information about a disease, condition, or physiological state.
- Often involving reagents, instruments, or software for analysis.
- Regulatory Classification: The device is classified under 21 CFR 880.6250, which is for Patient Examination Gloves. This classification is for general medical devices, not IVDs.
Patient examination gloves are considered medical devices, but they fall under a different regulatory category than IVDs. Their primary function is protection and barrier, not diagnosis.
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
A Powder-free Clear Vinyl Patient Examination Gloves 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 (21CFR 880.6250). Our Powder-free Clear Vinyl Patient Examination Gloves do not contain any UPS powder according to the results of testing conducted on the gloves. The residual powder testing is conducted per standards of ASTM D-6124-06, which demonstrates that the powder free glove is less than 2mg/pc. Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, LYZ, and meets all requirement of ASTM Standard 5250-06.
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
Non-clinical tests performed for Determination of Substantial Equivalence are as follows:
The standards used for Yongsheng Medical Products Co., Ltd glove production is based on ASTM-D5250-06. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 2.5.
The 1000ml. Water Fill Test was also conducted with samplings of AOL 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.
Our gloves meet our "powder-free" claims and contain no more than 2 mg powder per glove.
Key Metrics
Residual Powder:
§ 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
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized caduceus. To the right of it is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
March 9, 2018
Yongsheng Medical Products Co., Ltd % Melo Zhang Official Correspondent Intco Medical Industries, INC. 805 Barrington Ave Ontario, California 91764
Re: K173078
Trade/Device Name: Powder-free Clear Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: January 29, 2018 Received: February 2, 2018
Dear Melo Zhang:
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 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);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. 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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(k) SUMMARY K173078
-
- Submitter's Identification:
Yongsheng Medical Products Co., Ltd No. 4519 Qingzhou Road Shao De Industrial Park China Contact Person: Melo Zhang Official Correspondent
- Submitter's Identification:
Date summary prepared: March 6, 2018
-
- Name of the Device:
Yongsheng Medical Products Co., Ltd Powder-free Clear Vinyl Patient Examination Gloves
- Name of the Device:
-
- Trade Name
Yongsheng Medical Products Co., Ltd Powder-free Clear Vinyl Patient Examination Gloves
- Trade Name
-
- Predicate Device Information:
Powder-free PVC Vinyl Exam Gloves Hebei Grandeast Plastic Products Co.,Ltd. K 142703
- Predicate Device Information:
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5. Device Description:
A Powder-free Clear Vinyl Patient Examination Gloves 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 (21CFR 880.6250). Our Powder-free Clear Vinyl Patient Examination Gloves do not contain any UPS powder according to the results of testing conducted on the gloves. The residual powder testing is conducted per standards of ASTM D-6124-06, which demonstrates that the powder free glove is less than 2mg/pc. Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, LYZ, and meets all requirement of ASTM Standard 5250-06.
-
- Indication for Use:
A patient examination glove 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.
- Indication for Use:
-
- Technological Characteristic Comparison:
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| Device
Characteristics | Proposed Device | Predict Device
(K142703) | Comparison
Conclusion |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Product Name | Yongsheng Medical Products
Co., Ltd
Powder-free Clear Vinyl
Patient Examination Gloves | Hebei Grandeast Plastic
Products Co., Ltd.
Glide-On Vinyl
Examination Gloves | Similar |
| Product Code | LYZ | LYZ | Similar |
| Intended 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 | Similar |
| Length on Large
Size | Average over 232.23mm | >230 mm | Similar |
| Width of Palm on
Large Size | Average 95mm | >105 mm | Similar |
| Palm Thickness | Average 0.095 mm | 0.10 mm | Similar |
| Fingertip
Thickness | Average 0.09 mm | 0.10 mm | Similar |
| Residual Powder | According to ASTM D6124-
06 Standard Test Method for
Residual Powder on Medical
gloves for the determination
of residual powder content.
Testing result indicates the
weight of all types of residual
or powder on finished
powder-free gloves as 300% | Similar |
| After Aging:
Tensile Strength
(Mpa) and
Ultimate
Elongations | Average Tensile Strength
(Mpa): 14.96
Average Ultimate
Elongations:480.76% | Average Tensile Strength
(Mpa): 11
Average Ultimate Elongation
300% | Similar |
| Dermal
Sensitization | Under the conditions of the
study, the subject device is
not a sensitizer | Under the conditions of the
study, the subject device is not
a sensitizer | Similar |
| Summary | Yongsheng Medical Products Co., Ltd Powder-free Clear Vinyl Patient
Examination Gloves are similar to the predicate, K142703. | | |
-
- Discussion of Non-Clinical tests performed for Determination of Substantial Equivalence are as follows:
The standards used for Yongsheng Medical Products Co., Ltd glove production is based on ASTM-D5250-06. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 2.5.
- Discussion of Non-Clinical tests performed for Determination of Substantial Equivalence are as follows:
The 1000ml. Water Fill Test was also conducted with samplings of AOL 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.
Our gloves meet our "powder-free" claims and contain no more than 2 mg powder per glove.
-
- Conclusions:
The conclusions drawn from the nonclinical and clinical tests that demonstrate that the subject device is as safe, as effective, and performs as well as the predict device.
- Conclusions: