(87 days)
Not Found
No
The device is a disposable glove and the summary contains no mention of AI, ML, or related concepts.
No
The device, "Powder Free Grey Vinyl Patient Examination Gloves," is intended to prevent contamination between patient and examiner, not to provide therapy.
No.
The device is described as disposable gloves for preventing contamination, not for diagnosing any medical condition.
No
The device is described as "Powder Free Grey Vinyl Patient Examination Gloves," which are physical gloves and not software. The description focuses on the material, intended use, and physical characteristics.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is "worn on the examiner's hands or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection during physical examination, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description reinforces the intended use as a disposable glove for preventing contamination.
- 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 substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
- Performance Studies: The performance studies focus on physical properties and biocompatibility of the glove, which are relevant for a barrier device, not an IVD.
Therefore, the Powder Free Grey Vinyl Patient Examination Gloves are a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Powder Free Grey 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 Grey Vinvl 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 Grey 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
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 14, 2016
Zibo Flourish Trading Co., Ltd. % Ray Wang Official Correspondent Beijing Believe Tech. Service Co., Ltd. 5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd., LiYuan Town. Tongzhou Beijing, 101121 CHINA
Re: K161072
Trade/Device Name: Powder Free Grey Vinyl Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: June 24, 2016 Received: June 27, 2016
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.
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
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
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K161072
Device Name
Powder Free Grey Vinyl Examination Gloves
Indications for Use (Describe)
The Powder Free Grey 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Tab #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: K161072
-
- Date of Preparation: 2016-6-24
-
- Sponsor
ZIBO FLOURISH TRADING CO.,LTD NAQI ROAD,ZHANGDIAN DISTRICT,ZIBO CITY 255000,SHANDONG,P.R.CHINA
Contact Person: Ms. Kou Lingling 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 4.
Trade Name: Powder Free Grey Vinyl 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
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Intended Use Statement:
The Powder Free Grey 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 న్.
510(k) Number: K150224 Product Name: Blue Vinyl Examination Gloves Powder free Manufacturer: Zibo Sanying Trade Co., Ltd.
6. Device Description
The proposed device. Powder Free Grey Vinvl 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 Grey Vinyl Patient Examination Gloves, and includes variations of different size.
Non-Clinical Test Conclusion 7.
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.
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8. Substantially Equivalent Comparison Conclusion
| ITEM | Proposed Device
Powder Free Grey Vinyl Patient
Examination Gloves | Predicate Device (K150224)
BLUE VINYL GLOVES POWDER FREE | 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 Grey 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 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. | SE |
| Powdered or
Powered free | Powdered free | Powdered free | SE |
| Table III-1 General Comparison | |||
|---|---|---|---|
| -------------------------------- | -- | -- | -- |
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| Designation | Size | Tolerance | ||||||
|---|---|---|---|---|---|---|---|---|
| Proposed Device | ||||||||
| Powder Free Grey Vinyl Patient | ||||||||
| Examination Gloves | XS | S | M | L | XL | XXL | ||
| Length, mm | ≥230 | ≥230 | ≥230 | ≥230 | ≥230 | ≥230 | min | |
| Width, mm | 75 | 85 | 95 | 105 | 115 | 125 | ±5 | |
| Thickness, mm: | ||||||||
| Finger | ≥0.05 | min | ||||||
| Palm | ≥0.08 | min | ||||||
| Cuff | ≥0.06 | min | ||||||
| Predicate Device (K150224) | ||||||||
| BLUE VINYL GLOVES | ||||||||
| POWDER FREE | Size | Tolerance | ||||||
| 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 | Complies with ASTM D5250 |
Table III-3 Device Dimensions Comparison
| ITEM | Proposed Device | Predicate Device (K150224) | Remark | |
|---|---|---|---|---|
| Powder Free Grey Vinyl Patient | ||||
| Examination Gloves | BLUE VINYL GLOVES | |||
| POWDER FREE | ||||
| Colorant | Grey | Blue | Complies | |
| with ASTM | ||||
| D5250 | ||||
| Physical | ||||
| Properties | Before | |||
| Aging | ||||
| Tensile | ||||
| Strength | ≥12 MPa, min | ≥13 MPa, min | Complies | |
| with ASTM | ||||
| D5250 | ||||
| Ultimate | ||||
| Elongation | ≥300 % min | ≥400 % min | ||
| After | ||||
| Aging | ||||
| Tensile | ||||
| Strength | ≥12 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 | 1.8 mg per glove | Meet the requirements of ASTM | ||
| 5250 | SE |
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| ITEM | Proposed Device | Predicate Device (K150224) | Remark | |
|---|---|---|---|---|
| Powder Free Grey Vinyl Patient | ||||
| Examination Gloves | BLUE VINYL GLOVES POWDER | |||
| FREE | ||||
| 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 |
Table III-4Safety Comparison
Conclusion
The Zibo Flourish Tading Co., LTD Powder Free Grey Vinyl Patient Examination Glove is substantially equivalent to the predicate device, Zibo Sanying Trade Co., LTD. Blue Vinyl Examination Gloves Powder Free. 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, cleared under K150224.
The proposed device, Powder Free Grey Vinyl Patient Examination Gloves, is determined to be Substantially Equivalent (SE) to the predicate device in respect of safety and effectiveness.