(85 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of examination gloves, with 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, a patient examination glove, is intended to prevent contamination, not to diagnose medical conditions.
No
The device is a physical examination glove, which is a hardware medical device, not software. The summary describes physical properties and bench tests related to the glove's material and performance.
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 hands or finger to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description reinforces the barrier function of the glove.
- Lack of Diagnostic Activity: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on physical properties of the glove (tensile strength, freedom from holes, etc.) and biocompatibility, which are relevant to a barrier device, not a diagnostic one.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This glove does not perform any such function.
N/A
Intended Use / Indications for Use
The Vinyl patient examination glove, 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.
Product codes (comma separated list FDA assigned to the subject device)
LYZ
Device Description
The proposed device, Vinyl patient examination glove, 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.
The proposed is Powder Free Vinyl Patient Examination Gloves without color, and includes variations of different size.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ASTM D5250-06, Standard Specification for Poly(vinyl chloride) Gloves for Medical Application. ASTM D 5151-06 (Reapproved 2011), Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6124-06 (Reaffirmation 2011), Standard Test Method for Residual Powder on Medical Gloves.
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.
ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
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 logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid with three human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 26, 2016
Xingyuan Plastic Products Co., Ltd. % Mr. Ray Wang Official Correspondent Beijing Believe Tech. Service Co., Ltd. 1-202, Build 3, Beijing New World, No.5 Chaoyang Rd., Chaoyang District Beijing, 100024 CHINA
Re: K153159
Trade/Device Name: Vinyl Patient Examination Glove, Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: December 16, 2015 Received: December 18, 2015
Dear Mr. 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
1
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 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
Erin I. Keith, M.S. Division 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)
Device Name
Vinyl patient examination glove, Powder Free
Indications for Use (Describe)
The Vinyl patient examination glove, 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.
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) CONTINUE ON A SEPARATE PAGE IF NEEDED. 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 Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff
"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."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
EF
PSC Publishing Services (301) 443-6740
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Exhibit 2 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) Number: K153159
-
- Date of Preparation: 2016/01/26
-
- Sponsor
XINGYUAN PLASTIC PRODUCTS CO.,LTD. #100,CHANGDA ROAD, SIGEZHUANG, LUANNAN COUNTY, TangShan City, Hebei PROV., 063503, CHINA Contact Person: Mr. Qiwei Xing Tel: +86- 0315-4167693 Fax: +86-0315-4168700 Email: danny@zhonghongpulin.cn
- Submission Correspondent 3. Mr. Ray Wang Beijing Believe Tech. Service Co., Ltd. Tel: +86-21-50313932 Fax: +86-21-68093116 Email: Ray.Wang@believe-med.com
- Proposed Device Identification 4.
Trade Name: Vinyl patient examination glove, Powder Free Device Name: Vinyl Patient Examination Gloves (Powder Free) Common Name: Patient Examination Gloves
Classification: I Product Code: LYZ Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital
Intended Use Statement: The Vinyl patient examination glove, Powder Free, is a disposable device intended for medical
4
purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
-
- Predicate Device Identification
510(k) Number: K150224 Product Name: BLUE VINYL GLOVES POWDER FREE Manufacturer: ZIBO SANYING TRADE CO., LTD
- Predicate Device Identification
-
Device Description 6.
The proposed device, Vinyl patient examination glove, 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.
The proposed is Powder Free Vinyl Patient Examination Gloves without color, and includes variations of different size.
-
- Non-Clinical Test Conclusion
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
ASTM D5250-06, Standard Specification for Poly(vinyl chloride) Gloves for Medical Application. ASTM D 5151-06 (Reapproved 2011), Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6124-06 (Reaffirmation 2011), Standard Test Method for Residual Powder on Medical Gloves.
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.
ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
-
- Substantially Equivalent Comparison Conclusion
| ITEM | Proposed Device | Predicated Device | Remark |
|---|---|---|---|
| Vinyl patient examination glove, Powder | |||
| Free | BLUE VINYL GLOVES POWDER FREE | ||
| K150224 | |||
| Product Code | LYZ | LYZ | SE |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | SE |
| Class | I | I | SE |
Table 1 General Comparison
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| | The Vinyl patient examination glove,
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. | The BLUE VINYL 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. | |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|
| Intended Use | | | SE |
| Powdered or
Powered free | Powdered free | Powdered free | SE |
| Design Feature | ambidextrous, smooth | ambidextrous, smooth | SE |
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| Designation | Size | Tolerance | ||||
|---|---|---|---|---|---|---|
| Proposed Device | Length, mm | S | M | L | XL | |
| Vinyl patient examination glove, | ||||||
| Powder Free | Length, mm | 230 | 230 | 230 | 230 | min |
| Width, mm | 85 | 95 | 105 | 115 | ±5 | |
| Thickness, mm: | ||||||
| Finger | ≥ 0.05 | min | ||||
| Palm | 0.08 | min | ||||
| Designation | Size | Tolerance | ||||
| Predicate Device (K150224) | ||||||
| BLUE VINYL GLOVES | ||||||
| POWDER FREE | Length, mm | S | M | L | XL | |
| Length, mm | 240 | 240 | 240 | 240 | min | |
| Width, mm | 85 | 95 | 105 | 115 | ±5 | |
| Thickness, mm: | ||||||
| Finger | 0.10 | min | ||||
| Palm | 0.08 | min | ||||
| Remark | Analysis 1 |
Table 2 Device Dimensions Comparison
Analysis 1:
Although the proposed device has different with the predicated device in thickness of finger and palm, but the specifications of proposed device meet the requirements of ASTM D5250.
So we consider this as the proposed device is SE with the predicate device.
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| ITEM | | | Proposed Device
Vinyl patient examination glove,
Powder Free | Predicated Device
BLUE VINYL GLOVES
POWDER FREE
K150224 | Remark |
|------------------------|-----------------|------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------|------------|
| Colorant | | | N/A | Blue | Analysis 2 |
| Physical
Properties | Before
Aging | Tensile
Strength | 11 MPa, min | 13 MPa, min | Analysis 3 |
| | | Ultimate
Elongation | 300 % min | 400 % min | |
| | After
Aging | Tensile
Strength | 11 MPa, min | 13 MPa, min | |
| | | Ultimate
Elongation | 300 % min | 400 % min | |
| | | | Comply with ASTM D5250 | Comply with ASTM D5250 | SE |
| Freedom from Holes | | | Be free from holes when tested in
accordance with ASTM D5151 | Be free from holes when tested
in accordance with ASTM
D5151 | SE |
| Powder Content | | | 0.50 mg per glove | Meet the requirements of ASTM
5250 | SE |
| Table 3 Performance Comparison | |
|---|---|
Analysis 2:
The proposed device has no color rather than blue of the predicate device, this different may causes potential biocompatibility, for this risk we conducted the biocompatibility test according to the ISO 10993-10, the test results showed that the proposed devices did not induce skin irritation and showed no significant evidence of causing skin sensitization.
So we consider this as the proposed device is SE with the predicate device.
Analysis 3:
Although the proposed device has different with the predicated device in physical properties, but the specifications of proposed device meet the requirements of ASTM D5250.
So we consider this as the proposed device is SE with the predicate device.
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| ITEM | Proposed Device | Predicated Device | Remark | |
|---|---|---|---|---|
| Vinyl patient examination glove, | ||||
| Powder Free | BLUE VINYL GLOVES POWDER | |||
| FREE | ||||
| K150224 | ||||
| Material | Vinyl | Vinyl | SE | |
| Biocompatibility | Irritation | Under the conditions of the study, | ||
| not an irritant | Comply with ISO 10993-10 | SE | ||
| Sensitization | Under conditions of the study, not a | |||
| sensitizer. | SE | |||
| Label and Labeling | Single-use indication, powder free, | |||
| device name, glove size and quantity, | ||||
| Vinyl Examination Gloves, | ||||
| Non-Sterile | Single-use indication, powder free, | |||
| device name, glove size and quantity, | ||||
| Vinyl Examination Gloves, | ||||
| Non-Sterile | SE |
Table 4 Safety Comparison
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.