(79 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of a vinyl glove, with no mention of AI or ML technologies.
No
The device is a glove intended to prevent contamination, not to treat or diagnose a medical condition.
No
Explanation: The device is described as a glove intended to prevent contamination between a patient and an examiner. Its function is a barrier, not to diagnose any condition.
No
The device description clearly states it is a physical glove made of PVC film, intended to be worn on the hand or finger. It describes physical properties and testing related to the material and form factor, not software.
No, 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 hand or finger to prevent contamination between patient and examiner." This describes a barrier device used during physical examination or procedures, not a device used to examine specimens in vitro (outside the body).
- Device Description: The description focuses on the physical properties of the glove as a barrier. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: 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 diagnostic information based on sample analysis
- Using reagents or assays
The device is a medical device, specifically a patient examination glove, but its function is to provide a physical barrier, not to perform an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Product codes
LYZ
Device Description
PVC films form a barrier to prevent contamination between patient and examiner.
The PVC rubber is water tight under normal conditions of use. Its tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.
The Poly (vinyl chloride) glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner / 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)
The device meets the following standards:
- Dimensions: ASTM D 5250-06 (Reapproved 2011). Length ≥230mm. Width (Small 80-90 mm, Medium 90-100mm, Large 100-110mm, X large 110-120 mm). Thickness (Fingertip ≥0.05mm, Palm ≥0.08mm).
- Physical Properties: ASTM D 5250-06 (Reapproved 2011). Tensile strength (Before & After aging) ≥11MPa. Elongated rate (Before & After aging) ≥300%.
- Freedom from pinholes: 21 CFR 800.20 Passed Standard Acceptance Criteria. ASTM D5250-06 (Reapproved 2011). ASTM D5151-06 (Reapproved 2011).
- Powder Residual: ASTM standard D 5250-06 (Reapproved 2011) and D6124-06 (Reaffirmation 2011) Meets
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 15, 2017
Anhui Kindguard Medical Supplies Technology Co.,Ltd % Chu Xiaoan Official Correspondent Beijing Easylink CO., LTD Rm. F302 Bldg., 41, Jing Cheng Ya Ju, Courtyard 6 of Southern Dou Ge Zhuang, Beijing, 100121 CN
Re: K173017
Trade/Device Name: Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: September 16, 2017 Received: September 27, 2017
Dear Chu Xiaoan:
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 of medical device-related adverse events) (21 CFR 803); good
1
manufacturing practice requirements as set forth in 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.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K173017
Device Name
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Indications for Use (Describe)
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand 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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3
510(K) Summary
"The assigned 510(k) number is: K173017 ..............................................................................................................................................................................
Premarket Notification [510(k)] Summary
1.0 Submitter:
| Submitter's name: | Anhui Kindguard Medical Supplies
Technology Co.,Ltd |
|-------------------------|--------------------------------------------------------------------------------------------------|
| Submitter's address: | Intersection of Yulan Road and Chaoyang Road, Sixian County, Suzhou City,
Anhui,234300, China |
| Phone number: | 0086-557-7606789 |
| Fax number: | 0086-557-7606789 |
| Name of contact person: | Chen Wei |
| Date of preparation: | 2017-09-16 |
2.0 Name of th e Device
| Device Name: | Powder Free Vinyl Patient Examination
Gloves, Clear (non-colored) |
|-------------------------|--------------------------------------------------------------------------------|
| Proprietary/Trade name: | Kindguard Powder Free Vinyl Patient
Examination Gloves, Clear (non-colored) |
| CommonNam e | Exam gloves |
| Classification Name: | Patient examination glove |
| Device Class ification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital |
| Product Code: | LYZ |
3.0 Predicate device
| Device Name: | Powder-Free Vinyl Patient Examination Glove
(Non-colored) |
|----------------|--------------------------------------------------------------|
| Company name: | Zhang Jia Gang Fengyuan Plastic Product Co. Ltd. |
| 510(K) Number: | K091663. |
4.0 Device Description:
4.1 How the device functions:
PVC films form a barrier to prevent contamination between patient and examiner
4.2 Scientific concepts that form the basis for the device
The PVC rubber is water tight under normal conditions of use. Its tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.
4
4.3 Physical and performance characteristics such as design, materials and physical properties:
The Poly (vinyl chloride) glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151.
5.0 Device Intended Use (Indication for use):
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
6.0 Summary of the Technological Characteristics of the Device:
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Standard |
|---|---|
| Dimension | ASTM D 5250-06(Reapproved 2011). |
| Length ≥230mm | |
| Width Small 80-90 mm | |
| Medium 90-100mm | |
| Large 100-110mm | |
| X large 110-120 mm | |
| Thickness Fingertip ≥0.05mm | |
| Palm ≥0.08mm | |
| Physical | |
| Properties | ASTM D 5250-06(Reapproved 2011). |
| Tensile strength (Before & After aging) ≥11MPa | |
| Elongated rate (Before & After aging) ≥300% | |
| Freedom from | |
| pinholes | 21 CFR 800.20 Passed Standard Acceptance Criteria |
| ASTM D5250-06(Reapproved 2011) | |
| ASTM D5151-06(Reapproved 2011) | |
| Powder Residual | ASTM standard D 5250-06 (Reapproved 2011).and D6124-06(Reaffirmation 2011) Meets 14MPa |
9.0 Substantial Equivalence Comparison:
6
| | Holes at
Inspection Level
IAQL2.5 | Holes at
Inspection Level I
AQL2.5 | Holes at
Inspection Level I
AQL2.5 | Same |
|------------------------------------------------------------------------------------------------|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Freedom from
Pinholes | | | | |
| Residual
Powder | below 2mg of
residual powder | 0.3mg | 0.1mg | Same |
| Materials used to fabricate
the devices | | PVC | PVC | Same |
| Dusting or Donning
Powder: name | | Surface Coating Agent | Surface Coating Agent | Same |
| Compare performance data
supporting substantial
equivalence | | Meets
ASTM D5151-06
(Reapproved 2011)
ASTM D5250-06
(Reapproved 2011)
ASTM D6124-06
(Reaffirmation 2011) | Meets
ASTM D5151-06
(Reapproved 2011)
ASTM D5250-06
(Reapproved 2011)
ASTM D6124-06
(Reaffirmation 2011) | Same |
| Single Patient Use | | Single Patient Use | Single Patient Use | Same |
| Biocompatibility | | Under the conditions
of this study, not an
irritant and Under the
conditions of this
study, not a sensitizer.
SKIN IRRITATION
DERMAL and
SENSITIZATION
STUDIES Meets ISO
10993-10:2002/Amd.1
:2006 | Under the conditions
of this study, not an
irritant and Under the
conditions of this
study, not a
sensitizer.
SKIN IRRITATION
DERMAL and
SENSITIZATION
STUDIES Meets ISO
10993-10 Third
Edition 2010-08-01 | Same |
| Labeling for the legally
marketed device to which
substantial equivalence is
claimed. | | -Powder Free
-Patient Examination
Glove
-Single Use Only
- Manufactured For:
- Lot | -Powder Free
-Patient Examination
Glove
-Single Use Only - Manufactured For:
- Lot | Same |
Substantial Equivalence Comparison: 10.0
Discussion: The Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) meet the ASTM standard or equivalent standard and FDA requirements for water leak test on pinhole AQL., meeting labeling claims.
The subject device The Powder Free Vinyl Patient Examination Gloves, Clear (noncolored) has the same intended use and technological and performance characteristics as the predicate device Powder-Free Vinyl Patient Examination Glove (Non-colored) Zhang Jia Gang Plastic Product Co., Ltd. K091663, and therefore the devices are substantially equivalent.
Conclusion: The Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is as safe, as effective, and performs as well as the predicate device, Powder-Free Vinyl Patient Examination Glove (Non-colored) Zhang Jia Gang Plastic Product Co., Ltd. K091663.