K Number
K180260
Device Name
Powder Free Vinyl Patient Examination Gloves (Yellow, White)
Date Cleared
2018-06-12

(133 days)

Product Code
Regulation Number
880.6250
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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.
Device Description
Powder Free Vinyl Patient Examination Gloves (Yellow, White) 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.
More Information

Not Found

No
The device description and performance studies focus on the physical properties and material characteristics of examination gloves, with no mention of AI or ML.

No
The device, a patient examination glove, is intended for contamination prevention, not for directly treating or diagnosing a disease or condition, which are characteristics of a therapeutic device.

No
The device, a patient examination glove, is intended for preventing contamination and protecting the examiner, not for diagnosing medical conditions.

No

The device is a physical glove made of vinyl material, not software. The description details physical characteristics and performance tests related to the material and structure of the glove.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to prevent contamination between patient and examiner by being worn on the hand or finger. This is a physical barrier function, not a diagnostic test performed on a sample from the human body.
  • Device Description: The description focuses on the physical properties and performance characteristics of the glove material (vinyl, powder-free) and its compliance with a standard for medical gloves. It does not describe any components or processes related to analyzing biological samples.
  • Performance Studies: The performance studies listed are all non-clinical tests evaluating the physical integrity and safety of the glove itself (length, width, thickness, strength, pinholes, irritation, sensitization, cytotoxicity). There are no studies related to the accuracy or performance of a diagnostic test.
  • Key Metrics: The key metrics are physical measurements and material properties, not diagnostic performance metrics like sensitivity, specificity, or AUC.

IVD devices are designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease. This device does not perform any such test.

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 (Yellow, White) 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

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)

Non-Clinical Performance Tests:

  • Testing Items: Overall Length (mm), Inspection Level and AQL: S-2, AQL4.0, Actual Testing Results: S: 233-244mm M:231-241mm L:230-243mm XL: 234-242mm, Conclusion: Pass
  • Testing Items: Width (mm), Inspection Level and AQL: S-2, AQL4.0, Actual Testing Results: 87-88 mm 97-98 mm 107-108 mm 118-119 mm, Conclusion: Pass
  • Testing Items: Palm Thickness (mm), Inspection Level and AQL: S-2, AQL4.0, Actual Testing Results: 0.08mm, Conclusion: Pass
  • Testing Items: Finger Thickness (mm), Inspection Level and AQL: S-2, AQL4.0, Actual Testing Results: 0.09-0.12mm, Conclusion: Pass
  • Testing Items: Tensile Strength (Mpa) Before aging, Inspection Level and AQL: S-2, AQL4.0, Actual Testing Results: 15.1-18.1Mpa, Conclusion: Pass
  • Testing Items: Tensile Strength (Mpa) After aging, Inspection Level and AQL: S-2, AQL4.0, Actual Testing Results: 14.9-17.7Mpa, Conclusion: Pass
  • Testing Items: Ultimate Elongation (%) Before aging, Inspection Level and AQL: S-2, AQL4.0, Actual Testing Results: 390-470%, Conclusion: Pass
  • Testing Items: Ultimate Elongation (%) After aging, Inspection Level and AQL: S-2, AQL4.0, Actual Testing Results: 380-490%, Conclusion: Pass
  • Testing Items: Pinhole, Inspection Level and AQL: G-I, Actual Testing Results: meet AQL2.5 requirements, Conclusion: Pass
  • Testing Items: Residual Powder, Inspection Level and AQL: N=5, Actual Testing Results: 0.18 mg/glove, Conclusion: Pass
  • Testing Items: Primary Skin Irritation Test, Actual Testing Results: Under conditions of the study, not an irritant
  • Testing Items: Dermal Sensitization Study, Actual Testing Results: Under conditions of the study, not a sensitizer
  • Testing Items: Cytotoxicity Test, Actual Testing Results: Under the conditions of this study, not a cytotoxic potential

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K142570

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). 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.

June 12, 2018

Shanxi Hongjin Plastic Technology Co., Ltd % Kathy Liu Project Manager Hongray USA Medical Products Inc 3973 Schaefer Ave., Chino, CA 91710 US

Re: K180260

Trade/Device Name: Powder Free Vinyl Patient Examination Gloves (Yellow, White) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: May 16, 2018 Received: May 30, 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. 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 manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 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.

Elizabeth F. Claverie -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

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Indications for Use

510(k) Number (if known) K180260

Device Name

Powder Free Vinyl Patient Examination Gloves (Yellow, White)

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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Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province, China 042399

Product: Powder Free Vinyl Patient Examination Gloves (Yellow, White)

510(K) SUMMARY

The assigned 510(K) number is: K180260

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 Address: 3973 Schaefer Ave., Chino, CA 91710 Tel: 909-590-1611 Fax: 909-590-1511 Date Summary Prepared: May 16, 2018

2.Name of the Device:

Trade Name: Powder Free Vinyl Patient Examination Gloves (Yellow, White) 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 (Yellow, White, Blue, Pink) (K142570)

4. Device Description:

Powder Free Vinyl Patient Examination Gloves (Yellow, White) 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

Product: Powder Free Vinyl Patient Examination Gloves (Yellow, White)

5. Indications for Use Statement for these Devices:

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:

The properties between the subject device and the predicate device are compared in the following table:

| Characteristics | Device Performance | | Result of
comparison |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| | Predicate device | Subject Device | |
| 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 | Yellow White Blue Pink | Yellow White | Different |
| Specifications & Performance Data: | | | |
| physical Properties | Meets ASTM D 5250-06
(2015) requirements | Meets ASTM D 5250-06
(2015) requirements | Same |
| Freedom from
pinholes | Meets ASTM D 5250-06
(2015) requirements | 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
irritation test | Under conditions of the
study, not an irritant | Under conditions of the
study, not an irritant | Same |
| Dermal | 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

Product: Powder Free Vinyl Patient Examination Gloves (Yellow, White)

| Characteristics | Device Performance | | Result of
comparison |
|------------------------|-------------------------|-------------------------|-------------------------|
| | Predicate device | Subject Device | |
| sensitization
assay | study, not a sensitizer | study, not a sensitizer | |

Shanxi Hongjin Plastic Technology Co., Ltd's Powder Free Vinyl Patient Examination Gloves (Yellow, White) shares the same or comparable technology characteristics compared to the predicate device. The subject device performs according to the glove performance standards ASTM D5250-06(2015), biocompatibility requirement and FDA requirements and the labeling claims for the product.

7. Discussion of Non-Clinical Performance 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: 233-244mm
M:231-241mm
L:230-243mm
XL: 234-242mm | Pass | |
| Width
(mm) | S: 85±5
M: 95±5
L: 105±5
XL: 115±5 | S-2, AQL4.0 | 87-88 mm
97-98 mm
107-108 mm
118-119 mm | Pass | |
| Palm
Thickness
s (mm) | 0.08mm
minimum | S-2, AQL4.0 | 0.08mm | Pass | |
| Finger
Thickness
s (mm) | 0.05mm
minimum | S-2, AQL4.0 | 0.09-0.12mm | Pass | |
| Tensile Strength (Mpa) | Before aging
After aging | S-2, AQL4.0 | 11Mpa minimum
11Mpa minimum | 15.1-18.1Mpa
14.9-17.7Mpa | Pass
Pass |
| Ultimate Elongation (%) | Before aging
After aging | S-2, AQL4.0 | 300% minimum
300% minimum | 390-470%
380-490% | Pass
Pass |
| Pinhole | 2.5 | G-I | meet AQL2.5
requirements | Pass | |
| Residual | Not more than | N=5 | 0.18 mg/glove | Pass | |

6

Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province, China 042399

Product: Powder Free Vinyl Patient Examination Gloves (Yellow, White)

Powder2mg per glove
Primary Skin
Irritation TestUnder conditions of the study, not
an irritantUnder conditions of the study, not
an irritant
Dermal
Sensitization
StudyUnder conditions of the study, not
a sensitizerUnder conditions of the study, not
a sensitizer
Cytotoxicity
TestUnder the conditions of this
study, not a cytotoxic potentialUnder the conditions of this study,
not a cytotoxic potential

8.Clinical Performance Tests:

Clinical testing is not needed for this device.

9._Conclusion:

Shanxi Hongjin Plastic Technology Co., Ltd's Powder Free Vinyl Patient Examination Gloves (Yellow, White) conform fully to ASTM D 5250-06 (2015) standard as well as applicable 21 CFR references, and meets pinhole FDA requirements, biocompatibility requirements and labeling claims as shown by data discussed above. Based on the performed nonclinical tests, the device is as safe, as effective, and performs as well as the legally marketed predicate device.