(102 days)
Not Found
No
The device is a simple disposable glove and the summary contains no mention of AI, ML, or any related computational processing.
No.
The device (gloves) is intended to prevent contamination between patient and examiner, which is a prophylactic or protective function, not a therapeutic one. It does not treat or cure a disease or condition.
No
Explanation: The device is described as a glove intended to prevent contamination between patient and examiner, and its performance metrics relate to physical properties like tensile strength and freedom from holes, not to the detection or diagnosis of conditions.
No
The device is a physical product (gloves) and the summary describes bench tests related to material properties and physical standards, not software performance.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device's Intended Use: The intended use of these gloves is clearly stated as being 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 specimen.
- Lack of Diagnostic Activity: The description and performance metrics focus on the physical properties of the gloves (tensile strength, freedom from holes, powder content, biocompatibility) and their ability to act as a barrier. There is no mention of analyzing biological samples or providing diagnostic information.
Therefore, based on the provided information, the Powder Free Yellow Vinyl Patient Examination Gloves are a medical device, but they fall under the category of a barrier device for infection control, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Powder Free Yellow Vinyl Patient Examination Gloves 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, Powder Free Yellow Vinyl Patient Examination Gloves 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 Yellow Vinyl Patient Examination Gloves, 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
hands or finger
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)
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 19,2014
Zibo Huaqi Trading Company, Limited C/O Mr. Ray Wang Official Correspondent Beijing Believe Tech. Service Company, Limited 1-202, Build 3, Beijing New World, No.5 Chaoyang Rd., Chaoyang District, Beijing, 100024 CHINA
Re: K142508
Trade/Device Name: Powder Free Yellow Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient examination glove Regulatory Class: I Product Code: LYZ Dated: November 4, 2014 Received: November 7, 2014
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
1
Page 2 - Mr. Ray Wang
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-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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,
Susan Runno DDS, mA
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K142508
Device Name
Powder Free Yellow Vinyl Patient Examination Gloves
Indications for Use (Describe)
The Powder Free Yellow Vinyl Patient Examination Gloves 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) 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 Drug 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
conduct or sponsor, and a person is not required to respond to, a collection of agency may ﺃﻣﺎﻛﻦ ﻣﺄﻫﻮﻟﺔ ﺃﺳﺴﺖ ﻓﻲ 1970 ﻓﻲ ﺇﺳﺒﺎﻧﻴﺎ، ﻭﻳﺘﻢ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ 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
3
Exhibit #7 510(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: _
-
- Date of Preparation: Sept. 8, 2014
-
- Sponsor
ZIBO HUAQI TRADING CO., LTD YIFAN ROAD,ZHANGDIAN DISTRICT,ZIBO 255000,SHANDONG,P.R.CHINA
Contact Person: Ms. Jing Li Tel: +86- 0533-3819144 Fax: +86-0533-3818127 Email: hclijing85@126.com
- 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
Trade Name: Powder Free Yellow Vinyl Patient Examination Gloves 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
4
Intended Use Statement:
The Powder Free Yellow Vinyl Patient Examination Gloves 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.
-
- Predicate Device Identification
510(k) Number: K091431 Product Name: Patient Vinyl Examination Gloves, Yellow, Powder free Manufacturer: Zibo Yusheng Product Co., Ltd.
- Predicate Device Identification
6. Device Description
The proposed device, Powder Free Yellow Vinyl Patient Examination Gloves 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 Yellow Vinyl Patient Examination Gloves, 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.
5
8. Substantially Equivalent Comparison Conclusion
| ITEM | Proposed Device
Powder Free Yellow Vinyl
Patient Examination Gloves | Predicate Device (K091431)
Patient Vinyl Examination Gloves | Remark |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Code | LYZ | LYZ | SE |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | SE |
| Class | I | I | SE |
| Intended Use | The Powder Free Yellow Vinyl
Patient Examination Gloves 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. | A patient examination glove 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. | SE |
| Powdered or
Powered free | Powdered free | Powdered free | SE |
Table 1 General Comparison
6
| Proposed Device
Powder Free Yellow Vinyl
| Patient Examination Gloves | Designation | S | M | L | XL | Tolerance |
|---|---|---|---|---|---|---|
| Length, mm | 240 | 240 | 240 | 240 | min | |
| Width, mm | 85 | 95 | 105 | 115 | ±5 | |
| Thickness, mm: | ||||||
| Finger | 0.10 | min | ||||
| Palm | 0.08 | min | ||||
| Cuff | 0.06 | min | ||||
| Predicate Device (K091431) | ||||||
| Patient Vinyl Examination | ||||||
| Gloves | Designation | S | M | L | XL | Tolerance |
| Length, mm | 240 | 240 | 240 | 240 | min | |
| Width, mm | 85 | 95 | 105 | 115 | ±5 | |
| Thickness, mm: | ||||||
| Finger | 0.10 | min | ||||
| Palm | 0.08 | min | ||||
| Cuff | 0.06 | min | ||||
| Remark | SE |
Table 2 Device Dimensions Comparison
7
| Proposed Device | Predicate Device (K091431) | ||||
|---|---|---|---|---|---|
| ITEM | Powder Free Yellow Vinyl | ||||
| Patient Examination Gloves | Patient Vinyl Examination | ||||
| Gloves | Remark | ||||
| Colorant | Yellow | Yellow | SE | ||
| Physical | |||||
| Properties | Before | ||||
| Aging | Tensile | ||||
| Strength | 13 MPa, min | 13 MPa, min | SE | ||
| Ultimate | |||||
| Elongation | 400 % min | 400 % min | SE | ||
| After | |||||
| Aging | Tensile | ||||
| Strength | 13 MPa, min | 13 MPa, min | SE | ||
| Ultimate | |||||
| Elongation | 400 % min | 400 % min | SE | ||
| 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 | 0.61 mg per glove | Meet the requirements of ASTM | |||
| 5250 | SE |
Table 3 Performance Comparison
Table 4 Safety Comparison
| ITEM | Proposed Device
Powder Free Yellow Vinyl
Patient Examination Gloves | Predicate Device (K091431)
Patient Vinyl Examination Gloves | Remark |
|--------------------|---------------------------------------------------------------------------|----------------------------------------------------------------|--------|
| 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 | | |
| Label and Labeling | Meet FDA's Requirements | Meet FDA's Requirements | SE |
The proposed device, Powder Free Yellow Vinyl Patient Examination Gloves, is determined to be Substantially Equivalent (SE) to the predicate device in respect of safety and effectiveness.