(129 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a patient examination glove, with no mention of AI or ML technology.
No.
The device is a patient examination glove, intended to prevent contamination between patient and examiner, not to treat or alleviate a medical condition.
No
Explanation: The device, a patient examination glove, is described as preventing contamination between patient and examiner. Its intended use does not involve diagnosing any medical condition or disease.
No
The device description clearly states it is a physical, disposable glove made of vinyl, intended to be worn on the hands. It describes physical properties and testing related to the material and structure 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 function performed in vitro (outside the body).
- Device Description: The description reinforces the barrier function and mentions compliance with standards related to physical properties and biocompatibility, not diagnostic testing.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's condition.
- Regulatory Classification: The device is classified under 21 CFR 880.6250, which is for "Patient Examination Glove," a general and plastic surgery device, not an IVD classification.
- Performance Studies: The performance studies focus on physical properties (tensile strength, elongation), barrier integrity (pinholes), and biocompatibility (skin irritation, sensitization), all of which are relevant to a barrier device, not a diagnostic one.
In summary, the device's purpose is to provide a physical barrier during patient examination, which is a medical device function, but not an in vitro diagnostic function.
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
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, 80LYZ, and meets all requirement of ASTM Standard D5250-06.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hands or fingers of the examiner
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (for 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 performed for Determination of Substantial Equivalence:
The standards used for Shandong Zhiwei Medical Products Co., Ltd. glove production is based on ASTM-D-5250-06. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 2.5.
The FDA 1000 ml. 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.
Residual Powder: Tested 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
§ 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 24, 2017
Shandong Zhiwei Medical Products, Co. Ltd. % Melo Zhang Official Correspondent Intco Medical Industries, Inc. 805 Barrington Ave. Ontario, California 91764
Re: K171460
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: July 28, 2017 Received: May 18, 2017
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
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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 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 Industry and Consumer Education (DICE) 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 (DICE) 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, Tara A. Ryan -S 2017.09.24 19:33:34 -04'00'
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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Indications for Use
510(k) Number (if known) K171460
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)
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510 (K) SUMMARY
1. Submitter's Identification:
Shandong Zhiwei Medical Products Co., Ltd. No. 4519 Oingzhou Road Shao De Industrial Park China Contact Person: Melo Zhang Official Correspondent
Date summary prepared: September 13, 2017
2. Name of the Device:
Shandong Zhiwei Medical Products Co., Ltd. Powder-free Clear Vinyl Patient Examination Gloves Classification Name: Patient Examination Glove Product Code: LYZ Product Class: Class I Regulation #: 21 CFR 880.6250 Classification Panel: General Hospital
3. Trade Name
Shandong Zhiwei Medical Products Co., Ltd. Powder-free Clear Vinyl Patient Examination Gloves
4. Predicate Device Information:
Shijiazhuang Star Plastic Co., Ltd. Powder Free Vinyl Examination Gloves - (K100699)
Tangshan Zhonghong Pulin Food Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves - (K022091)
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
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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, 80LYZ, and meets all requirement of ASTM Standard D5250-06.
6. 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 (21CFR 880.6250)
7. Comparison to Predicate Devices:
Table 7-2. Side-by-Side Comparison of Intended Use, Design, Material, Physical, Biocompatibility, and Performance Testing
| | Proposed Device
(K171460) | Predicate Device
(K022091) | Predicate Device
(K100699) | | | |
|--------------------------------|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|---------------------|------------------------|------------------------|
| Description | Shandong Zhiwei Medical
Products Co., Ltd. Powder-free
Clear Vinyl Patient Examination
Gloves | Tangshan
Zhonghong Pulin
Food Products Co.,
Ltd Class I vinyl
patient examination
gloves, powder-free | Shijiazhuang Star
Plastic Co., Ltd
Powder Free Vinyl
Patient
Examination
Gloves | | | |
| | Indication 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 | similar | similar | | |
| | | Basic Design | A garment covering the hand and
wrist area. Clovers have separate
sheaths or openings for each finger
and the thumb. | similar | similar | |
| | | | Materials Used | Poly Vinyl Chloride | Poly Vinyl
Chloride | Poly Vinyl
Chloride |
| | | | Single Use | Yes | Yes | Yes |
| | | Sterile | Not sterile | Not sterile | Not sterile | |
| Length on Large
Size | Average over 231.62mm | Similar | Similar | | | |
| Width of Palm
on Large Size | Average 95mm | Similar | Similar | | | |
| Palm Thickness | Average 0.095 mm | Similar | Similar | | | |
| Fingertip
Thickness | Average 0.09 mm | Similar | Similar | | | |
| Residual Powder | According to ASTM D6124-06
Standard Test Method for Residual | Similar | Similar | | | |
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| | 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