(268 days)
Not Found
No
The device is a simple physical barrier (gloves) and the description focuses on material properties and physical performance characteristics, with no mention of AI or ML.
No.
The device is described as a "patient examination glove" intended to "prevent contamination between patient and examiner," which is a protective barrier function, not a therapeutic action.
No
Explanation: The device is described as "a patient examination glove" intended "to prevent contamination between patient and examiner." Its function is protective, not diagnostic.
No
The device is a physical examination glove made of vinyl, not software. The description details material properties and physical performance tests.
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, tissue) to provide information about a person's health. This includes tests for diagnosis, monitoring, screening, and prognosis.
- Device Description and Intended Use: The provided information clearly states that the device is a "patient examination glove" intended to be worn on the hand or finger to prevent contamination between the patient and examiner. It's a physical barrier device.
- Lack of Specimen Analysis: There is no mention of the glove being used to analyze any biological specimens or provide diagnostic information based on such analysis.
- Performance Studies: The performance studies focus on the physical properties and safety of the glove itself (tensile strength, pinholes, skin irritation, etc.), not on its ability to perform a diagnostic test on a specimen.
Therefore, based on the provided information, the device is a medical device used for barrier protection, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
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 D5250-06 (Reapproved 2015) 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
Hand or finger
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 performed to demonstrate that the device is as safe, as effective, and performs as well as the legally marketed predicate device. Tests included: Overall Length, Width, Palm Thickness, Finger Thickness, Tensile Strength (Before and After aging), Ultimate Elongation (Before and After aging), Pinhole, Residual Powder, Primary Skin Irritation Test, Dermal Sensitization Study, and Cytotoxicity Test. All tests passed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Overall Length (S: 233-241mm, M:231-242mm, L:230-244mm, XL: 234-245mm)
Width (S: 87-88 mm, M: 97-98 mm, L: 107-108 mm, XL: 118-119 mm)
Palm Thickness (0.08mm)
Finger Thickness (0.09-0.11mm)
Tensile Strength (Before aging: 14.4-17.1Mpa; After aging: 14.1-16.9Mpa)
Ultimate Elongation (Before aging: 390-480%; After aging: 380-470%)
Pinhole (meet AQL2.5 requirements)
Residual Powder (0.20 mg/glove)
Primary Skin Irritation Test (not an irritant)
Dermal Sensitization Study (not an irritant)
Cytotoxicity Test (not a cytotoxic potential)
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
November 7, 2018
Shanxi Hongjin Plastic Technology Co., Ltd Kathy Liu Project Manager Hongray USA Medical Products Inc 3973 Schaefer Ave. Chino, California 91710
Re: K180381
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: September 26, 2018 Received: October 2, 2018
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-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,
Clarence W. Murray lii III -S
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
2
Indications for Use
510(k) Number (if known) K180381
Device Name
Powder Free Vinyl Patient Examination Gloves
Indications for Use (Describe)
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.
| 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
Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province, China 042399
Trade Name: Powder Free Vinyl Patient Examination Gloves
510(K) SUMMARY
This summary of 510(K) is being submitted in accordance with 21 CFR 807.92.
The assigned 510(K) number is: K180381
1. Owner's Identification:
Mr. Wu Zhigang Shanxi Hongjin Plastic Technology Co., LTD Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province, China 042399
Tel: 86-311-66179653 Fax: 86-311-83616934
Contact: Ms. Kathy Liu, Project Manager or Ms Monica Yu Address: 3973 Schaefer Ave., Chino, CA 91710 Tel: 909-590-1611 Fax: 909-590-1511 Date Summary Prepared: November 5, 2018
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:
Ever Light Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves (K142571)
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 D5250-06 (Reapproved 2015) Standard Specification For Poly(Vinyl Chloride) Gloves For Medical Application.
4
Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province, China 042399
Trade Name: Powder Free Vinyl Patient Examination Gloves
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 Characteristic Comparison Table:
Shown below is the comparison of technological characteristic between the subject and predicate device.
| Characteristics | Device Performance | | Result of
comparison |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| | Predicate device
K142571 | Subject Device K180381 | |
| Product Code | LYZ | LYZ | 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 | There are no special
labeling claims | Same |
| Device Materials | Vinyl | Vinyl | Same |
| Color | Clear | Clear | Similar |
| Specifications & Performance Data: | | | |
| physical Properties | 11Mpa minimum
Elongation 300%
Meets ASTM D 5250-06
(2015)requirements | 11Mpa minimum
Elongation:300%
Meets ASTM D 5250-06
(2015)requirements | Same |
| Freedom from
pinholes | G -1,AQL 2.5
Meets ASTM D 5250-06
(2015)requirements | G -1,AQL 2.5
Meets ASTM D 5250-06
(2015)requirements | Same |
| Dimensions: | Meets ASTM D 5250-06
(2015)requirements | Meets ASTM D 5250-06
(2015)requirements | Same |
| Residual powder | Meets Applicable
Definition for Powder
Free; ≤ 2 mg per glove | Meets Applicable
Definition for Powder
Free; ≤ 2 mg per glove | Same |
| Biocompatibility
Primary skin | Under conditions of the | Under conditions of the | Same |
5
Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province, China 042399
Trade Name: Powder Free Vinyl Patient Examination Gloves
| Device Performance | Result of | ||
|---|---|---|---|
| Characteristics | Predicate device | ||
| K142571 | Subject Device K180381 | comparison | |
| irritation test | study, not an irritant | study, not an irritant | |
| Dermal | |||
| sensitization | |||
| assay | Under conditions of the | ||
| study, not an irritant | Under conditions of the | ||
| study, not an irritant | Same | ||
| Cytotoxicity Test | / | Under the conditions of | |
| this study, not a cytotoxic | |||
| potential | Different |
Shanxi Hongjin Plastic Technology Co., Ltd's Powder Free Vinyl Patient Examination Gloves shares the same or similar technology characteristics compared to the predicate device.
7. Discussion of Non-Clinical Tests
| Testing Items | FDA-recognized
Standard
Requirements | Inspection
Level and AQL | Actual Testing
Results | Conclusion |
|-----------------------------|--------------------------------------------|-----------------------------|-------------------------------------------------------------|------------|
| Overall
Length
(mm) | 230 for all sizes
minimum | S-2, AQL4.0 | S: 233-241mm
M:231-242mm
L:230-244mm
XL: 234-245mm | Pass |
| Width
(mm) | S: 85 ± 5 | S-2, AQL4.0 | 87-88 mm | Pass |
| | M: 95 ± 5 | | 97-98 mm | |
| | L: 105±5 | | 107-108 mm | |
| | XL: 115±5 | | 118-119 mm | |
| Palm
Thickness
(mm) | 0.08mm
minimum | S-2, AQL4.0 | 0.08mm | Pass |
| Finger
Thickness
(mm) | 0.05mm
minimum | S-2, AQL4.0 | 0.09-0.11mm | Pass |
| Tensile Strength (Mpa) | | | | |
| Before aging | 11Mpa minimum | S-2, AQL4.0 | 14.4-17.1Mpa | Pass |
| After aging | 11Mpa minimum | | 14.1-16.9Mpa | Pass |
| Ultimate Elongation (%) | | | | |
| Before aging | 300% minimum | S-2, AQL4.0 | 390-480% | Pass |
| After aging | 300% minimum | | 380-470% | Pass |
6
Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province, China 042399
| Pinhole | 2.5 | G-I | meet AQL2.5 requirements | Pass |
|---|---|---|---|---|
| Residual | ||||
| Powder | Not more than | |||
| 2mg per glove | N=5 | 0.20 mg/glove | Pass | |
| (a) Primary | ||||
| Skin | ||||
| Irritation Test | Under conditions of the study, not | |||
| an irritant | Under conditions of the study, not | |||
| an irritant | ||||
| (b) Dermal | ||||
| Sensitization | ||||
| Study | Under conditions of the study, not | |||
| an irritant | Under conditions of the study, not | |||
| an irritant | ||||
| (c)Cytotoxicity | ||||
| Test | Under the conditions of this study, | |||
| not a cytotoxic potential | Under the conditions of this study, | |||
| not a cytotoxic potential |
Trade Name: Powder Free Vinyl Patient Examination Gloves
8. Discussion of Clinical Tests Performed:
Not applicable
9. Conclusion:
Based on the performed nonclinical tests, demonstrate that the device is as safe, as effective, and performs as well as the legally marketed predicate device.