(145 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI or ML.
No
The device is a patient examination glove, intended to prevent contamination between patient and examiner, not to provide therapy.
No
The device is described as a glove intended to prevent contamination, not to diagnose a condition.
No
The device is a physical glove, not software. The description clearly outlines a tangible product made of vinyl and subject to physical performance and biocompatibility testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic test performed on a sample from the human body.
- Device Description: The description focuses on the physical characteristics and standards met for a glove, not on any reagents, instruments, or procedures used for in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies listed (ASTM standards, biocompatibility testing) are related to the physical properties, integrity, and safety of the glove for its intended barrier use, not diagnostic accuracy.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Powder free vinyl patient examination glove, colored (yellow) is a non-sterile, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Product codes
LYZ
Device Description
Powder free vinyl patient examination glove, colored (yellow) are patient examination gloves available in S, M, L, XL. They are provided non-sterile and meet the entire requirement of ASTM standard D5250-06(reapproved), except for sterility requirements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner / Not Found
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)
The following performance data were provided in support of the substantial equivalence determination.
- ASTM D5250-06
- ASTM D5151-06
- ASTM D6124-06
Biocompatibility testing
The biocompatibility evaluation for the subject device was conducted in accordance with the FDA draft guidance Use of international standard ISO-10993, "Biological evaluation of medical device part 1: Evaluation and testing," dated April 23, 2013 and international standard ISO10993-1 "Biological evaluation of medical devices-part 1: Evaluation and testing within a risk management process," as recognized by FDA. The group of testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation
The subject device is considered to be a surface device, contacting intact skin, for duration of less than 24hours.
Key Results:
Cytotoxicity: Per ISO10993-5, under the conditions tested, the subject glove is non-cytotoxic.
Biocompatibility: Per ISO10993-10, under the conditions tested, the subject glove was non-sensitizing and non-irritating.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Dimension: Length: >= 230mm, Width: S Size 85+/-5mm, M Size 95+/-5mm, L Size 105+/-5mm, XL Size 115+/-5mm, Finger thickness >= 0.05mm, Palm thickness >= 0.08mm.
Physical properties: Tensile strengthen >= 11MPa, Elongation >= 300%.
Freedom from pinholes: Pinhole=0/200, AQL 2.5.
Powder residual: Powder residual=0.5mg per glove.
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 seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 2, 2016
Kaixing Plastic Products Co., Ltd. % Daniel Qiu Project Manager Lichen Commercial Information Consulting Co., Ltd. Room 1304, Building 8, Yuntai Rd. 453 Pudong New District, Shanghai, CN 200126
Re: K160675
Trade/Device Name: Powder free vinyl patient examination glove, colored (yellow) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: June 24, 2016 Received: June 24, 2016
Dear Mr. Qiu:
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.
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Tina Kiang, Ph.D. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160675
Device Name
Powder free vinyl patient examination glove, colored(yellow)
Indications for Use (Describe)
Powder free vinyl patient examination glove, colored (yellow) is a non-sterile, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | ---------------------------------------------------------------------------------------------- |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
I, Submitter's information
Name: KAIXING PLASTIC PRODUCTS CO., LTD. Address: 1101 Tanggang Road Luannan County Tangshan City, Hebei Province China Contact person: Danny Xing Telephone: +86-315-4167693 Fax: +86-315-4168700
II. Date prepared
May 27, 2016
III, Device
Name of the device: Powder free vinyl patient examination glove, colored (yellow) Classification name: Patient examination glove Regulation class: 1 Regulation number: 21CFR 880.6250 Panel: General hospital Product code: LYZ
IV, Predicative device
K143277, White vinyl patient examination glove, Life safety products (Hui Zhou) Co., Ltd.
V, Device description
Powder free vinyl patient examination glove, colored (yellow) are patient examination gloves available in S, M, L, XL. They are provided non-sterile and meet the entire requirement of ASTM standard D5250-06(reapproved), except for sterility requirements.
VI, Indication for use
Powder free vinyl patient examination glove, colored (yellow) is a non-sterile, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
VII, Summary of comparison of technological characteristics with the predicative device
4
At a high level, the subject and predicative devices are based on the following same technological elements:
| Description | Powder free vinyl patient
examination glove,
colored(yellow)
Subject device(K160675) | White vinyl patient
examination glove(non-sterile)
Predicate device(K143277) | Comments |
|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Intended use | Powder free vinyl patient examination glove, colored (yellow) is disposable device intended for medical purposes that is worn on the examiner's hand 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 |
| Material | Poly vinyl Chloride | Poly vinyl Chloride | Substantially
Equivalent |
| Sizes | S,M,L, XL | S,M,L,XL | Substantially
Equivalent |
| Single use | Yes | Yes | Substantially
Equivalent |
| Sterility | Non-sterile | Non-sterile | Substantially
Equivalent |
There are no significant technological differences between the subject and predicate device:
| Characteristics | Powder free vinyl patient
examination
colored(yellow) | White vinyl patient
examination
glove(non-sterile)
Predicate device(K143277) | Comments |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Dimension | Length: $\geq$ 230mm
Width:
S Size 85±5mm
M Size 95±5mm
L Size 105±5mm
XL Size 115±5mm
Finger thickness $\geq$ 0.05mm
Palm thickness $\geq$ 0.08mm
Meets ASTM D5250-06 | Length: 243mm
Width:
S Size=85mm
M Size=95mm
L Size=105mm
XL Size=115mm
Finger thickness=0.05mm
Palm thickness=0.08mm
Meets ASTM D5250-06 | Substantially
Equivalent |
| Physical properties | Tensile strengthen $\geq$ 11MPa
Elongation $\geq$ 300%
Meets ASTM D5250-06 | Tensile strengthen=15.7MPa
Elongation=385%
Meets ASTM D5250-06 | Substantially
Equivalent |
| Freedom from pinholes | Pinhole=0/200
AQL 2.5
Meets ASTM D5151-06 | Pinhole=10/500
AQL 1.5
Meets ASTM D5151-06 | Substantially
Equivalent |
5
| Powder residual | Powder residual=0.5mg per
glove
Meets ASTM D5250-06 and
D6124-06 | Powder residual= 1mg
Meets ASTM D5250-06 and
D6124-06 | Substantially
Equivalent |
|------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Cytotoxicity | Per ISO10993-5, under the
conditions tested, the subject
glove is non-cytotoxic. | Per ISO10993-5, under the
conditions tested, the subject
glove is non-cytotoxic. | Substantially
Equivalent |
| Biocompatibility | Per ISO10993-10, under the
conditions tested, the subject
glove was non-sensitizing and
non-irritating. | Per ISO10993-10, under the
conditions tested, the subject
glove was non-sensitizing
and non-irritating. | Substantially
Equivalent |
VIII, Performance data
The following performance data were provided in support of the substantial equivalence determination.
- ASTM D5250-06
- ASTM D5151-06
- ASTM D6124-06
Biocompatibility testing
The biocompatibility evaluation for the subject device was conducted in accordance with the FDA draft guidance Use of international standard ISO-10993, "Biological evaluation of medical device part 1: Evaluation and testing," dated April 23, 2013 and international standard ISO10993-1 "Biological evaluation of medical devices-part 1: Evaluation and testing within a risk management process," as recognized by FDA. The group of testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation
The subject device is considered to be a surface device, contacting intact skin, for duration of less than 24hours.
IX, Conclusions
The Kaixing Plastic Products Co., LTD powder free vinyl patient examination glove, colored(yellow) is substantially equivalent to the predicate device, Lifestyle Safety Products, Co, LTD White vinyl patient examination glove (non-sterile). Based on the non-clinical tests performed, the subject device is as safe, as effective and performs as well as the legally marketed predicate device, Lifestyle Safety Products, Co, LTD White vinyl patient examination glove (non-sterile) cleared under K143277.