(101 days)
Not Found
No
The device description and performance studies focus on the physical properties and safety standards of examination gloves, with no mention of AI or ML capabilities.
No
The device is described as examination gloves used to prevent contamination, not to treat or cure a disease or condition.
No
Explanation: The device, Vinyl Examination Gloves, is described as a disposable device for preventing contamination between patient and examiner. Its function is protective, not diagnostic, as it does not gather or interpret data to identify a medical condition.
No
The device is a physical product (examination gloves) and the description focuses on material properties and physical testing, not software functionality.
No, 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 hands 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 focuses on the physical properties and testing related to the glove's integrity and safety for skin contact. There is no mention of reagents, assays, or any components used to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
The device is a medical device, specifically a Class I medical device (examination glove), but it falls under the category of a barrier device for infection control, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Vinyl Examination Gloves (White, Blue, or Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LYZ
Device Description
The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is available in three different colors: White, Blue, and Yellow. The proposed device was tested according to the following standards: ASTM D 6124-06, ASTM D 5151-06, ASTM D5250-06, ISO 10993-10:2010 and ISO 2859-1:2009.The proposed device is non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical tests were conducted to verify that the proposed device met all specifications and the proposed device is Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- ASTM D6124-06 (Reaffirmation 2011), Standard Test Method for Residual Powder on Medical Gloves
- ASTM D 5151-06 (Reapproved 2011), Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D5250-06, Standard Specification for Poly(vinyl chloride) Gloves for Medical Application.
- ISO 2859-1:1999, "Sampling Procedures for Inspection by Attributes Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection.
No clinical study is included in this submission.
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
Image /page/0/Picture/1 description: The image shows the text "Public Health Service". The text is in a bold, sans-serif font. The text is black and the background is white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 23, 2017
Hebei Hongtai Plastic Products Company Limited % Ray Wang Official Correspondent Beijing Believe Tech.service Co., Ltd. 5-1206, Build 332, Dafangju, No.25 Banbidian Rd., Liyuan Tongzhou District Beijing, 101121 CN
Re: K163168
Trade/Device Name: Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: January 14, 2017 Received: January 17, 2017
Dear Ray Wang:
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 device
1
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 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,
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K163168
Device Name
Vinyl Examination Gloves (White) Vinyl Examination Gloves (Blue) Vinyl Examination Gloves (Yellow)
Indications for Use (Describe)
The Vinyl Examination Gloves (White, Blue, or Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hands 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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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW! *
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
510(k) Summary
The assigned 510(k) Number: K163168
-
- Date of Preparation:2017/02/23
-
- Sponsor Identification
Hebei Hongtai Plastic Products Company Limited.
No. 15, Luban Road, Julu County, Xingtai, Hebei Province 055250, China Establishment Registration Number: Not yet registered
Contact Person: Liu Wei Position: General Manager Tel: +86-319-4362370 Fax: +86-319-4362371 Email: nedvidel@handform.cn
-
- Designated Submission Correspondent
Mr. Ray Wang
- Designated Submission Correspondent
Beijing Believe Tech. Service Co., Ltd
Tel: +86-18910677558, Fax: +86-21-68093116 Email: Ray.Wang@believe-med.com
4
-
- Identification of Proposed Device
Trade Name: Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow): Common Name: Vinyl Patient Examination Gloves (Powder Free) Model(s): XS S M L XL
- Identification of Proposed Device
Regulatory Information Classification Name: Patient Examination Glove Classification:I Product Code: LYZ Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital
Indication for use Statement:
The Vinyl Examination Gloves (White, Blue, or Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
-
- Device Description
The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is available in three different colors: White, Blue, and Yellow. The proposed device was tested according to the following standards: ASTM D 6124-06, ASTM D 5151-06, ASTM D5250-06, ISO 10993-10:2010 and ISO 2859-1:2009.The proposed device is non-sterile.
- Device Description
-
- Identification of Predicate Device(s)
Predicate Device K150224 Blue Vinyl Examination Gloves Powder Free ZIBO SANYING TRADE CO., LTD
- Identification of Predicate Device(s)
-
- Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all specifications and the proposed device is Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
-
ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
-
ASTM D6124-06 (Reaffirmation 2011), Standard Test Method for Residual Powder on Medical Gloves
-
A ASTM D 5151-06 (Reapproved 2011), Standard Test Method for Detection of Holes in Medical Gloves.
5
-
ASTM D5250-06, Standard Specification for Poly(vinyl chloride) Gloves for Medical Application.
- ISO 2859-1:1999, "Sampling Procedures for Inspection by Attributes Part I: Sampling > Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection.
- Clinical Test Conclusion 8.
No clinical study is included in this submission.
6
| ITEM | Proposed Device
(K163168) | Predicate Device (K150224)
Blue Vinyl Examination Gloves Powder
Free | Remark |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Code | LYZ | LYZ | Same |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Vinyl Examination Gloves (White, Blue, or Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. | The Blue Vinyl Examination Gloves Powder Free is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. | Same |
| Powdered or
Powered free | Powdered free | Powdered free | Same |
| Design Feature | ambidextrous | ambidextrous | Same |
| Labeling
Information | Single-use indication, powder free, device color, device name, glove size and quantity, Vinyl Examination Gloves, Non-Sterile | Single-use indication, powder free, device color, device name, glove size and quantity, Vinyl Examination Gloves, Non-Sterile | Same |
9. Substantially Equivalent (SE) Comparison
Table 1 General Comparison
7
| Designation | Size | Tolerance | |||||
|---|---|---|---|---|---|---|---|
| XS | S | M | L | XL | |||
| Proposed Device | |||||||
| (K163168) | Length, mm | 230 | 230 | 235 | 245 | 245 | min |
| Width, mm | 80 | 85 | 95 | 105 | 115 | $\pm 5$ | |
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.08 | min | |||||
| Predicate Device (K150224) | |||||||
| Blue Vinyl Examination Gloves | |||||||
| Powder Free | Designation | Size | Tolerance | ||||
| S | M | L | XL | ||||
| Length, mm | 240 | 240 | 240 | 240 | min | ||
| Width, mm | 85 | 95 | 105 | 115 | $\pm 5$ | ||
| Thickness, mm: | |||||||
| Finger | 0.10 | min | |||||
| Palm | 0.08 | min | |||||
| Remark | Analysis 1 |
Table 2 Device Dimensions Comparison
Analysis 1:
The proposed device has different size specifications as compared to the predicate device, but the proposed device meets the specifications of ASTM D5250.
8
| ITEM | | Proposed Device
(K163168) | Predicate Device (K150224)
Blue Vinyl Examination Gloves
Powder Free | Remark | |
|------------------------|-----------------|-------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|-------------|------------|
| Colorant | | White, Blue, Yellow | Blue | Analysis 2 | |
| Physical
Properties | Before
Aging | Tensile
Strength | 15 MPa, min | 13 MPa, min | |
| | | Ultimate
Elongation | 380 % min | 400 % min | |
| | After
Aging | Tensile
Strength | 15 MPa, min | 13 MPa, min | Analysis 3 |
| | | Ultimate
Elongation | 380 % min | 400 % min | |
| Comply with ASTM D5250 | | | Comply with ASTM D5250
11 MPa min./300% min. | Same | |
| Freedom from Holes | | Be free from holes when tested in
accordance with ASTM D5151
AQL 1.5 | Be free from holes when tested
in accordance with ASTM
D5151 under AQL 2.5/Inspection
Level G-I | Same | |
| Powder Content | | 0.50 mg per glove (White)
0.60 mg per glove (Blue)
0.70 mg per glove (Yellow) | Meet the requirements of ASTM
D5250
Less than 2mg per glove | Same | |
Table 3 Performance Comparison
Table 4 Safety Comparison
| ITEM | Proposed Device
(K163168) | Predicate Device (K150224)
Blue Vinyl Examination Gloves
Powder Free | Remark | |
|--------------------|------------------------------|----------------------------------------------------------------------------|----------------------------|------|
| Material | Vinyl | Vinyl | Same | |
| Biocompatibility | Irritation | Under the conditions of the study,
not an irritant | Comply with ISO 10993-10 | Same |
| | Sensitization | Under conditions of the study, not a
sensitizer. | | Same |
| Label and Labeling | | Meet FDA's Recommendations | Meet FDA's Recommendations | Same |
Analysis 2:
The proposed device has different colors as compared to the predicate device. This difference may cause potential biocompatibility risks. To address this concern, we evaluated the biocompatibility testing according to the standard ISO 10993-10. The results showed that the proposed devices (White, Blue, Yellow) did not induce skin irritation and skin sensitization.
9
The proposed device has different Ultimate Elongation after aging as compared to the predicate device, but the proposed device meets the specifications of ASTM D5250.
-
- Substantially Equivalent (SE) Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.
- Substantially Equivalent (SE) Conclusion