Powder-Free Clear Vinyl Patient Examination Gloves

K190095 · Anhui Intco Medical Products Co., Ltd. · LYZ · Jun 20, 2019 · General Hospital

Device Facts

• Record ID: K190095
• Device Name: Powder-Free Clear Vinyl Patient Examination Gloves
• Applicant: Anhui Intco Medical Products Co., Ltd.
• Product Code: LYZ · General Hospital
• Decision Date: Jun 20, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Indications for Use

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiners' hands or fingers to prevent contamination between patients and examiners

Device Story

Powder-free clear vinyl patient examination gloves; single-use disposable; worn on hands/fingers by examiners to prevent cross-contamination. Manufactured from poly vinyl chloride (PVC). Available in sizes small, medium, large, and extra-large. Non-sterile. Used in clinical settings to provide a barrier between patient and examiner. Output is a physical barrier; no electronic or software components. Benefits include protection against contamination during medical examinations.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ASTM D5250-06 (dimensions/physical properties), ASTM D5151-06 (pinhole/leak test, AQL 2.5), and ASTM D6124-06 (residual powder < 2 mg/glove). Biocompatibility confirmed via ISO 10993-10 (skin irritation/sensitization) and ISO 10993-5 (cytotoxicity).

Technological Characteristics

Material: Poly vinyl chloride (PVC). Form factor: Disposable, non-sterile, powder-free gloves. Sizes: S, M, L, XL. Standards: ASTM D5250-06 (physical properties), ASTM D5151-06 (leak test), ASTM D6124-06 (residual powder), ISO 10993-10 (biocompatibility), ISO 10993-5 (cytotoxicity). No energy source, connectivity, or software.

Indications for Use

Indicated for use as a disposable medical glove worn on examiner hands or fingers to prevent cross-contamination between patients and examiners. Suitable for use by clinicians or for over-the-counter applications.

Regulatory Classification

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.

Predicate Devices

• Vinyl Examination Gloves, Powder-Free, Clear (K022091)

Submission Summary (Full Text)

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June 20, 2019

Anhui Intco Medical Products Co. Ltd % Derek Tian Official Correspondent Intco Medical Industries, Inc. 805 Barrington Ave Ontario. California 91764

Re: K190095

Trade/Device Name: Powder-Free Clear Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: March 21, 2019 Received: March 26, 2019

Dear Derek Tian:

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.

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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) 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For Elizabeth Claverie, M.S. THT4B2: Disinfection, Reprocessing and Personal Protection Acting Assistant Director, THT4B1: Sterility Devices DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known)

K190095

Device Name

Powder-free clear vinyl patient examination gloves

Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiners' hands or fingers to prevent contamination between patients and examiners

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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Image /page/3/Picture/0 description: The image contains a logo with the text "INTCO" in blue, with a stylized blue graphic above it resembling a flower or sunburst. Below "INTCO" are smaller Chinese characters. To the right, the text "Anhui Intco Med" is written in bold, black letters. The overall design appears to represent a company or organization, possibly in the medical field, based in Anhui.

Anhui Intco Medical Products Co,Itd

No. 1 Haitang Road, Suixi District economic development area, Huaibei City, Anhui Province

# 510(k) SUMMARY

## K190095

This summary of 510(k) is being submitted in accordance 21 CFR §807.92.

Date summary prepared: June 19, 2019

### 1. Submitter's Identification:

Anhui Intco Medical Products Co, Ltd. No.1 Haitang Road, Suixi District economic development area Huaibei City, Anhui Province China

### Contact Person

Jacken Cai Product Manager Tel: [phone] Email: [e-mail]

## US Representative Contact Person

Dongqi Tian Tel: [phone] Email: [e-mail]

- 2. Name of the Device: Powder-free Clear Vinyl Patient Examination Gloves
- 3. Common Name: Patient Examination Gloves
- 4. Regulation number: 21 CFR 880.6250
- 5. Class: I
- Product Code: LYZ 6.
- 7. Predicate Device Information:

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Device name: Vinyl Examination Gloves, Powder-Free, Clear 510(k) #: K022091 Manufacturer name: Tangshan Zhonghong Pulin Food Products Co., Ltd

#### 8. Device Description:

The Vinyl Examination Gloves are single use only, disposable gloves intended for medical purposes to be worn on the hands or fingers of examiners. The gloves are powder-free, clear and are made of poly vinyl chloride. The gloves are offered non-sterile and are available in small, medium, large and extra-large sizes.

#### 9. Indication for Use:

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patients and examiners.

#### 10. Technological Characteristics

Side by side comparison (including technological characteristics) between subject and predicate device

| | Proposed Device<br>(K190095) | Predicate Device<br>(K022091) | Comparison<br>Conclusions |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Device Name | Powder-free Clear<br>Vinyl Patient<br>Examination Gloves | Vinyl Examination<br>Gloves, Powder-Free,<br>Clear | Similar |
| Manufacturer | Anhui Intco Medical<br>Products Co, Itd. | Tangshan Zhonghong<br>Pulin Food Products<br>Co., Ltd. | Different |
| Indication for use | A patient examination<br>glove is a disposable<br>device intended for<br>medical purposes that<br>is worn upon the<br>examiner's hands or<br>fingers to prevent<br>contamination<br>between patients and<br>examiners. | A Vinyl patient<br>examination glove is a<br>disposable device<br>intended for medical<br>purposes worn on the<br>examiner's hand or<br>finger to prevent<br>contamination<br>between patient and<br>examiner. | Same |
| Labeling: Labels on<br>the carton | Face: Proprietary<br>name, common name,<br>contents size, lot<br>number, distributed by<br>Side: Proprietary<br>name, Indications for<br>Use contents, size, lot<br>number, distributed<br>by, country and<br>instruction for<br>storage" Store in a<br>cool and dry place.<br>Avoid Direct sunlight | N/A | Different |

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| Labels on the<br>dispenser glove | | Face: Powder-free<br>Clear Vinyl Patient<br>Examination Gloves,<br>non-sterile, single use<br>only, contents: 100<br>gloves (by weight) size,<br>manufactured for:<br>Intco Medical<br>Industries, Inc. or<br>other importers.<br><br>Side: Powder-free<br>Clear Vinyl Patient<br>Examination Gloves,<br>non-sterile, single use<br>only Contents: 100<br>gloves (by weight),<br>size, lot number,<br>distributed by:<br>Manufactured for: | Face: Vinyl<br>examination Glove<br>Powder-free,<br>Contents: 100 gloves<br>(by weight) Size: <<br>Distributed by: Baldur<br>systems Corp.<br>Hayward, CA 94545<br><br>Side: Vinyl<br>Examination Glove<br>Powder-free/Single<br>Use/Non-sterile,<br>Content: 100 gloves<br>(by weight) Size, made<br>in China, Lot number | Similar | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Device Materials | | Poly Vinyl Chloride | Poly Vinyl Chloride | Similar | |
| Color | | Clear | Clear | Same | |
| Technological<br>Characteristics as<br>per ASTM 5250-06<br>(Reapproved<br>2011) (FDA<br>recognition #:<br>6-183)<br>Standard<br>Specification for<br>Poly (Vinyl<br>Chloride) Gloves<br>for Medical<br>Applications | | Before Aging:<br>Tensile<br>Strength(Mpa)<br>and Ultimate<br>Elongations<br><br>After Aging:<br>Tensile<br>Strength(Mpa)<br>and Ultimate<br>Elongations<br><br>Available Sizes | Average Tensile<br>Strength (Mpa): 17.44<br><br>Average Ultimate<br>Elongations: 519.4%<br><br>Average Tensile<br>Strength (Mpa): 15<br><br>Average Ultimate<br>Elongations: 481.96%<br><br>S, M, L, XL | Average Tensile<br>Strength (Mpa): 17.00<br><br>Average Ultimate<br>Elongations: 500%<br><br>Average Tensile<br>Strength (Mpa): 15<br><br>Average Ultimate<br>Elongations: 450%<br><br>S, M, L, XL | Similar<br><br>Similar<br><br>Same |
| | | Overall Length<br>on Medium Size<br><br>Width of Palm<br>on Medium Size<br><br>Palm Thickness<br><br>Finger Thickness | Average over<br>232.23mm<br><br>Average 95.08mm<br><br>Average 0.095 mm<br><br>Average 0.090 mm | Average over<br>232.23mm<br><br>Average 95.08mm<br><br>Average 0.095 mm<br><br>Average 0.090 mm | Same<br><br>Same<br><br>Same<br><br>Same |
| Residual Powder<br>ASTM D6124-06<br>of residual or powder on finished<br>powder-free gloves as < 2 mg per<br>glove. | | | Meets ASTM D6124-06<br>Residual powder on<br>finished powder-free<br>gloves was < 2 mg per<br>glove | Meets ASTM D6124-06<br>Residual powder on<br>finished powder-free<br>gloves was < 2 mg per<br>glove | Same |
| Pinhole /Water Leak Test<br>According to ASTM D5151-06,<br>(Reapproved 2011)<br>Sample 4, AQL 2.5 | | | Meets ASTM D5151-06<br>According to ASTM<br>D5151-06. Testing<br>result indicated<br>pinhole were found in<br>two gloves out of 125<br>gloves examined. AQL<br>2.5 . Criteria was met | Meets ASTM D5151-06<br>According to ASTM<br>D5151-06. Testing<br>result indicated<br>pinhole were found<br>two gloves out of 125<br>gloves. AQL 2.5 was<br>met. | Same |
| -Biocompatibility | Primary Skin<br>Irritation<br>ISO 10993-<br>10:2010<br>ISO Skin<br>Irritation Study | Under the conditions<br>of the study, the test<br>material was not an<br>irritant in the white<br>rabbit model. | Under the conditions<br>of the study, the test<br>material was not an<br>irritant in the white<br>rabbit model. | Same | |
| | Dermal<br>Sensitization<br>ISO 10993-<br>10:2010<br>ISO Skin Dermal<br>Sensitization | Under the conditions<br>of the study, an extract<br>of this test material<br>was not a sensitizer in<br>the Guinea pig model. | Under the conditions<br>of the study, an extract<br>of this test material<br>was not a sensitizer in<br>the Guinea pig model. | Same | |
| | Cytotoxicity<br>ISO 10993-<br>5:2009<br>Biological<br>Evaluation of<br>Medical Devices-<br>Part 5: Test For<br>In Vitro<br>Cytotoxicity.<br>Acceptance<br>criteria : Cells<br>treated with<br>neat extract<br>from tested<br>article are not<br>lysed | Under conditions of<br>the study, the device<br>extract is not cytotoxic<br>to the mammalian cell<br>culture (mouse<br>fibroblasts L929 cells) | N/A | Different | |

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### 11. Summary of Non-Clinical Performance Data

The subject device was tested using the methodologies recommended in the following standards and the results met the acceptance criteria in the standards:

i) ASTM 5250-06 (Reapproved 2011) (FDA recognition # 6-183) Standard Specification for Poly (Vinyl Chloride) Gloves for Medical Applications Acceptance Criteria: Length: ≥ 230 mm (min) Width (size Medium): 90-100 mm Thickness Finger 0.05 mm (min) Thickness Palm 0.08 mm (min) The subject device testing results meets all acceptance criteria.

ii) ASTM D5151-06 (FDA recognition #: 6-175) Standard Test for Detection of Holes in Medical Gloves Standard acceptance criteria: Results: Meets ASTM D5151-06 Sampling -4 AQL 2.5 of 125 gloves tested, 2 gloves were found to leak.

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iii) ASTM D6124-06 (FDA recognition #: 6-178) Standard Test Method to Determine the Amount of Residual Powder and Non-powder Solids on Medical Gloves.

Standard acceptance criteria: Powder residue < 2 g per glove Results: Meets ASTM D6124-06. We found that our gloves had 2 mg/glove of residual powder.

iv) ISO 10993-10: 2010 Biological Evaluation of Medical Devices-Part 10: test for Irritation and Skin sensitization.Standard acceptance criteria: No skin irritation in the white rabbit model and no skin sensitization in the guinea pig model.

Results: Meets ISO 10993-10:2010

Skin Irritation: Under the condition of the test, the device extracts were not an irritant.

Skin Sensitization: Under the condition of the test, the device extracts were not a sensitizer.

v) ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Test for in vitro Cytotoxicity

Standard acceptance criteria: The percent of cytotoxicity should not be greater than 30% when cells are exposed to neat test article extract.

Results: Under the condition of the test, the neat extracts was not cytotoxicity

# 12. Summary of Clinical Performance Data

NA

### 13. Conclusion:

The conclusions drawn from the nonclinical tests demonstrate that the subject device (K190095) is as safe. as effective, and performs as well as or better than the legally marketed predicate device (K022091).