(88 days)
Not Found
No
The device is a simple examination glove and the description and testing focus on material properties and physical performance, with no mention of AI/ML.
No.
The device, "Powder Free Vinyl Patient Examination Gloves," is described as a disposable device worn on the examiner's hand to prevent contamination, not to provide therapy or treatment to a patient.
No
Explanation: The device, Powder Free Vinyl Patient Examination Gloves, is described as a disposable device intended for medical purposes worn to prevent contamination. Its function is to provide a barrier, not to diagnose a condition or disease.
No
The device description clearly states it is a physical glove made of vinyl material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gloves are "worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the physical properties and performance characteristics of the gloves as a barrier (meeting ASTM standards for medical gloves).
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing information about a patient's health status.
- Performance Studies: The performance studies focus on the physical integrity, biocompatibility, and powder content of the gloves, which are relevant to their barrier function and safety, not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This description of the gloves does not align with that definition.
N/A
Intended Use / Indications for Use
Powder Free Vinyl Patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Product codes
LYZ
Device Description
Powder Free Vinyl Patient Examination Gloves Are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-19 Standard Specification for Poly (Vinyl Chloride) Gloves for Medical Application.
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)
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
- ISO 10993-10:2010 Biological Evaluation of Medical Devices Part 10: Tests for Irritation . and Skin Sensitization.
- . ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity
- ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves
- ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D5250-19, Standard Specification for Poly (Vinyl Chloride) Gloves for Medical Application
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
| Characteristics | FDA-recognized Standard | Inspection Level and AQL | Performance Results | Conclusion |
|---|---|---|---|---|
| Overall Length (mm) | ASTM D 5250-19 230 for all sizes minimum | S-2, AQL4.0 | S: 235-241mm M:233-240mm L:234-241mm XL: 236-242mm | Meets |
| Width (mm) ASTM D 5250- 19 | S: 85±5 M: 95±5 L: 105±5 XL: 115±5 | S-2, AQL4.0 | 86-88 mm 96-98 mm 106-108 mm 116-118 mm | Meets |
| Palm Thickness (mm) | 0.08mm minimum | S-2, AQL4.0 | 0.08mm | Meets |
| Finger Thickness (mm) | 0.08mm minimum | S-2, AQL4.0 | 0.08-0.10mm | Meets |
| Tensile Strength (Mpa) ASTM D 5250-19: Before aging | 11Mpa minimum | S-2, AQL4.0 | 13.0-16.1Mpa | Meets |
| After aging | 11Mpa minimum | 13.0-15.8Mpa | Meets | |
| Ultimate Elongation (%): Before aging | 300% minimum | S-2, AQL4.0 | 310-410% | Meets |
| After aging | 300% minimum | S-2, AQL4.0 | 310-400% | Meets |
| Pinhole | ASTM D 5250-19 ASTM D5151-19 21CFR800.20 | G-I, AQL2.5 | 125 glove sampled and 1 piece leaks | Meets |
| Residual Powder | ASTM D 5250-19 ASTM D6124-06 (Reapproved 2017) | Not more than 2mg per glove N=5 | 0.35-0.73mg | Meets |
| Primary Skin Irritation and Skin Sensitization | ISO 10993-10 | / | Under conditions of the study, not an irritant | Meets |
| Cytotoxicity Test | ISO 10993-5 | / | Under the conditions of this study, no cytotoxic potential | Meets |
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image contains 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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 17, 2021
Shijiazhuang Hongjun Plastic Manufacture Co., Ltd. % Kathy Liu Project Manager Hongray USA Medical Products Inc. 3973 Schaefer Avenue Chino, California 91710
Re: K211177
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: April 14, 2021 Received: April 20, 2021
Dear Kathy Liu:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211177
Device Name
Powder Free Vinyl Patient Examination Gloves
Indications for Use (Describe)
Powder Free Vinyl Patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand 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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3
Xinye Industrial Zone, Wangtong Village, Wancheng Town, Gaoyi County, Shijiazhuang City, Hebei Province, 051330 China
Product: Powder Free Vinyl Patient Examination Gloves
510(K) SUMMARY
This summary of 510(K) is being submitted in accordance with requirements of 21 CFR $807.92.
The assigned 510(K) number is: K211177 Date Prepared: July 16, 2021
1. Owner's Identification:
Mr. Lv Zhanmin Shijiazhuang Hongjun Plastic Manufacture Co., Ltd. Xinye Industrial Zone, Wangtong Village, Wancheng Town, Gaoyi County, Shijiazhuang City, Hebei Province, 051330 China Tel: 86-311-83610904
Contact: Ms. Kathy Liu, Project Manager Address: 3973 Schaefer Ave., Chino, CA 91710 Tel: 909-590-1611
2. Name of the Device:
Trade Name: Powder Free Vinyl Patient Examination Gloves Common Name: Exam Gloves Classification Name: Patient Examination Glove Classification Regulation: 880.6250 Classification Panel: 880 General Hospital and Personal Use Product Code: LYZ Device Class: Class I
3. Predicate Device Information:
Shanxi Hongjin Plastic Technology Co., Ltd Powder Free Vinyl Patient Examination Gloves- (K180381)
4. Device Description:
Powder Free Vinyl Patient Examination Gloves Are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-19 Standard Specification for Poly (Vinyl Chloride) Gloves for Medical Application.
5. Intended Use of the Device:
A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
6. Technological Characteristics Comparison:
Shijiazhuang Hongjun Plastic Manufacture Co., Ltd's Powder Free Vinyl Patient Examination Gloves is compared to the Shanxi Hongjin Plastic Technology Co., Ltd's Powder Free Vinyl Patient Examination Gloves- (K180381) in the table below.
4
Xinye Industrial Zone, Wangtong Village, Wancheng Town, Gaoyi County,
| Characteristics | Standard | Device Performance | Result of | ||
|---|---|---|---|---|---|
| Predicate device | Subject Device | comparison | |||
| Product Code | / | LYZ | LYZ | Same | |
| Size | / | S, M, L, XL | S, M, L, XL | Same | |
| Intended Use | / | Predicate device is | |||
| disposable non-sterile | |||||
| device intended for | |||||
| medical purpose that is | |||||
| worn on the | |||||
| examiner's hand or | |||||
| finger to prevent | |||||
| contamination | |||||
| between patient and | |||||
| examiner. | Subject device is | ||||
| disposable non-sterile | |||||
| device intended for | |||||
| medical purpose that is | |||||
| worn on the | |||||
| examiner's hand or | |||||
| finger to prevent | |||||
| contamination | |||||
| between patient and | |||||
| examiner. | Same | ||||
| Labeling | / | There are no special | |||
| labeling claims and do | |||||
| not claim gloves as | |||||
| hypoallergenic on | |||||
| labels. | There are no special | ||||
| labeling claims and do | |||||
| not claim gloves as | |||||
| hypoallergenic on | |||||
| labels. | Same | ||||
| Device Materials | / | Vinyl | Vinyl | Same | |
| Color | / | Clear | Clear | Same | |
| Device tolerances and specifications & Performance Data: | |||||
| Tensile strength: | |||||
| before | |||||
| and | |||||
| after | |||||
| aging | ASTM D 5250- | ||||
| 19 | 11Mpa minimum | 11Mpa minimum | Same | ||
| Ultimate elongation: | |||||
| before | |||||
| and | |||||
| after | |||||
| aging | ASTM D 5250- | ||||
| 19 | 300% minimum | 300% minimum | Same | ||
| Freedom from | |||||
| pinholes | ASTM D 5250- | ||||
| 19 | G-I, AQL2.5 | G-I, AQL2.5 | Same | ||
| Dimensions: Overall | |||||
| length, Width, Palm | |||||
| and | |||||
| Finger | |||||
| thickness | ASTM D 5250- | ||||
| 19 | Meets ASTM D 5250- | ||||
| 19 | Meets ASTM D 5250- | ||||
| 19 | Same | ||||
| Residual powder | ASTM D 5250- | ||||
| 19 | Not more than 2 mg | ||||
| per glove | Not more than 2 mg | ||||
| per glove | Same | ||||
| Biocompatibility | |||||
| Primary skin | |||||
| irritation test | ISO 10993-10 | Under conditions of | |||
| the study, not an | |||||
| irritant | Under conditions of | ||||
| the study, not an | |||||
| irritant | Same | ||||
| Dermal sensitization | ISO 10993-10 | Under conditions of | Under conditions of | Same | |
| Characteristics | Standard | Device Performance | Result of comparison | ||
| Predicate device | Subject Device | ||||
| assay | the study, not an | ||||
| irritant | the study, not an | ||||
| irritant | |||||
| Cytotoxicity Test | ISO 10993-5 | Under the conditions | |||
| of this study, no | |||||
| cytotoxic potential | Under the conditions | ||||
| of this study, no | |||||
| cytotoxic potential | Same |
Product: Powder Free Vinyl Patient Examination Gloves
5
Xinye Industrial Zone, Wangtong Village, Wancheng Town, Gaoyi County, Shijiazhuang City, Hebei Province, 051330 China
Product: Powder Free Vinyl Patient Examination Gloves
Shijiazhuang Hongjun Plastic Manufacture Co., Ltd's Powder Free Vinyl Patient Examination Gloves shares the same or comparable technology characteristics compared to the predicate device. The subject device performs according to the glove performance standards ASTM D5250-19, biocompatibility requirement and FDA requirements and the labeling claims for the product..
7. Summary of Non-Clinical Tests:
| Characteristics | FDA-recognized
Standard | Inspection Level
and AQL | Performance Results | Conclusion |
|---------------------------------------------------------|------------------------------------------------------|---------------------------------------|-------------------------------------------------------------|------------|
| Overall Length
(mm) | ASTM D 5250-19
230 for all sizes
minimum | S-2, AQL4.0 | S: 235-241mm
M:233-240mm
L:234-241mm
XL: 236-242mm | Meets |
| Width (mm)
ASTM D 5250-
19 | S: 85±5
M: 95±5
L: 105±5
XL: 115±5 | S-2, AQL4.0 | 86-88 mm
96-98 mm
106-108 mm
116-118 mm | Meets |
| Palm Thickness
(mm) | 0.08mm minimum | S-2, AQL4.0 | 0.08mm | Meets |
| Finger
Thickness (mm) | 0.08mm minimum | S-2, AQL4.0 | 0.08-0.10mm | Meets |
| Tensile Strength (Mpa) ASTM D 5250-19 | | | | |
| Before aging | 11Mpa minimum | S-2, AQL4.0 | 13.0-16.1Mpa | Meets |
| After aging | 11Mpa minimum | | 13.0-15.8Mpa | Meets |
| Ultimate Elongation (%) | | | | |
| Before aging | 300% minimum | S-2, AQL4.0 | 310-410% | Meets |
| After aging | 300% minimum | S-2, AQL4.0 | 310-400% | Meets |
| Pinhole | ASTM D 5250-19
ASTM D5151-19
21CFR800.20 | G-I, AQL2.5 | 125 glove sampled
and 1 piece leaks | Meets |
| Residual Powder | ASTM D 5250-19
ASTM D6124-06
(Reapproved 2017) | Not more than
2mg per glove
N=5 | 0.35-0.73mg | Meets |
| Primary Skin
Irritation and
Skin
Sensitization | ISO 10993-10 | / | Under conditions of
the study, not an
irritant | Meets |
6
Xinye Industrial Zone, Wangtong Village, Wancheng Town, Gaoyi County, Shijiazhuang City, Hebei Province, 051330 China
Product: Powder Free Vinyl Patient Examination Gloves
| Cytotoxicity
Test | ISO 10993-5 | / | Under the conditions
of this study, no
cytotoxic potential | Meets |
| ---------------------- | ------------- | --- | ------------------------------------------------------------------ | ------- |
|---|
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
- ISO 10993-10:2010 Biological Evaluation of Medical Devices Part 10: Tests for Irritation . and Skin Sensitization.
- . ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity
- ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves
- ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves. ●
- ASTM D5250-19, Standard Specification for Poly (Vinyl Chloride) Gloves for Medical Application
Clinical Performance Data 8.
N/A
9. Conclusion:
The conclusions drawn from the nonclinical and clinical tests demonstrate that the subject device, Powder Free Vinyl Patient Examination Gloves (K211177) is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Powder Free Vinyl Patient Examination Gloves (K180381).