(99 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI, ML, or any related technologies.
No
The device, examination gloves, is intended to prevent contamination, not to treat or alleviate a medical condition.
No
Explanation: The device is described as an examination glove intended to prevent contamination, not to diagnose a condition.
No
The device is described as physical examination gloves, which are hardware, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device's Intended Use: The intended use of the BLUE VINYL EXAMINATION GLOVES POWDER FREE is clearly stated as being worn on the hands or fingers to prevent contamination between patient and examiner. This is a barrier function, not a diagnostic test performed on a sample.
- Lack of Diagnostic Function: The device description and performance studies focus on the physical properties and safety of the glove (strength, hole detection, powder residue, biocompatibility). There is no mention of analyzing biological samples or providing diagnostic information.
Therefore, based on the provided information, the BLUE VINYL EXAMINATION GLOVES POWDER FREE is a medical device, but it falls under the category of a barrier device rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LYZ
Device Description
The proposed device, 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.
The proposed is BLUE VINYL EXAMINATION GLOVES POWDER FREE, 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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 12, 2015
ZIBO SANYING TRADE CO., LTD C/O 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: K150224 Trade/Device Name: Blue Vinyl Examination Gloves Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Vinyl Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: March 29, 2015 Received: April 1, 2015
Dear Mr. 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.
1
Page 2 - Mr. Wang
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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
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Section II Indications for Use
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K150224
Device Name
BLUE VINYL EXAMINATION GLOVES POWDER FREE
Indications for Use (Describe)
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.
| 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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Section III 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: K150224
-
- Date of Preparation: 2015/1/30
-
- Sponsor
ZIBO SANYING TRADE CO., LTD XILV VILLAGE FANGZHEN , ZHANGDIAN DISTRICT, ZIBO , SHANDONG , 255000 , 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: BLUE VINYL EXAMINATION GLOVES 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
5
Intended Use Statement:
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.
-
- Predicate Device Identification
510(k) Number: K142508 Product Name: Powder Free Yellow Vinyl Examination Gloves Manufacturer: Zibo HUAQI TRADING Co., Ltd.
- Predicate Device Identification
6. Device Description
The proposed device, 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.
The proposed is BLUE VINYL EXAMINATION GLOVES POWDER FREE, 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 8.
| ITEM | Proposed Device | Predicate Device (K142508) | Remark |
|---|---|---|---|
| BLUE VINYL EXAMINATION GLOVES | Powder Free Yellow Vinyl |
Table 1 General Comparison
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| POWDER FREE | Patient Examination Gloves | ||
|---|---|---|---|
| Product Code | LYZ | LYZ | SE |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | SE |
| Class | I | I | SE |
| Intended Use | 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. | 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. | SE | ||
| Powdered or | |||
| Powered free | Powdered free | Powdered free | SE |
| Table 2 Device Dimensions Comparison | ||
|---|---|---|
| -------------------------------------- | -- | -- |
| Size | Tolerance | ||||||
|---|---|---|---|---|---|---|---|
| Designation | S | M | L | XL | |||
| Proposed Device | |||||||
| BLUE VINYL EXAMINATION | |||||||
| GLOVES POWDER FREE | Length, mm | 240 | 240 | 240 | 240 | ||
| Width, mm | 85 | 95 | 105 | 115 | ±5 | ||
| Thickness, mm: | |||||||
| Finger | 0.10 | min | |||||
| Palm | 0.08 | min | |||||
| Cuff | 0.06 | min | |||||
| Predicate Device (K142508) | |||||||
| Powder Free Yellow Vinyl | |||||||
| Patient Examination Gloves | Designation | 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 | |||||
| Cuff | 0.06 | min | |||||
| Remark | SE |
Table 3 Performance Comparison
| ITEM | Proposed Device | Predicate Device (K142508) | Remark | ||
|---|---|---|---|---|---|
| BLUE VINYL EXAMINATION | Powder Free Yellow Vinyl | ||||
| GLOVES POWDER FREE | Patient Examination Gloves | ||||
| Colorant | Blue | Yellow | Analysis | ||
| Physical | |||||
| Properties | Before | ||||
| Aging | Tensile | ||||
| Strength | 13 MPa, min | 13 MPa, min | SE | ||
| Ultimate | |||||
| Elongation | 400 % min | 400 % min | SE | ||
| After | Tensile | 13 MPa, min | 13 MPa, min | SE |
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| Aging | Strength | ||||
|---|---|---|---|---|---|
| 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 | 0.50 mg per glove | Meet the requirements of ASTM | |||
| 5250 | SE |
Table 4 Safety Comparison
| ITEM | Proposed Device | Predicate Device (K142508) | Remark | |
|---|---|---|---|---|
| BLUE VINYL EXAMINATION | ||||
| GLOVES POWDER FREE | Powder Free Yellow Vinyl | |||
| Patient Examination Gloves | ||||
| 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 color of the proposed device is different from the color of the predicate device. This difference may potentially cause biocompatibility issues. In order to mitigate this risk, we conducted biocompatibility tests according to ISO 10993-10 and the test results demonstrated that the proposed device with blue colorant did not induce skin irritation and showed no significant evidence of causing skin sensitization.
The proposed device, BLUE VINYL EXAMINATION GLOVES POWDER FREE, is determined to be Substantially Equivalent (SE) to the predicate device in respect of safety and effectiveness.