Nitrile Examination Gloves

K212929 · Watchtower Ppe Supplies, Inc. · LZA · Apr 9, 2022 · General Hospital

Device Facts

• Record ID: K212929
• Device Name: Nitrile Examination Gloves
• Applicant: Watchtower Ppe Supplies, Inc.
• Product Code: LZA · General Hospital
• Decision Date: Apr 9, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A powder free 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. The device is for over-the-counter use.

Device Story

Nitrile examination gloves; disposable; non-sterile; ambidextrous; blue; finger-textured. Worn by clinicians or patients (OTC) to provide barrier protection against cross-contamination. Manufactured from nitrile (butyronitrile latex). Device provides physical barrier; tested for tensile strength, elongation, and freedom from holes. Used in general medical environments. Benefits include protection of both patient and examiner from contamination during examinations.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM D6319-19 (dimensions, physical properties), ASTM D5151-19 (watertightness/holes), and ASTM D6124-06 (residual powder). Biocompatibility confirmed via ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), and ISO 10993-11 (systemic toxicity).

Technological Characteristics

Material: Nitrile (butyronitrile latex). Form: Ambidextrous, finger-textured, blue, non-sterile. Sizes: S-XL. Standards: ASTM D6319-19, ASTM D5151-19, ASTM D6124-06, ISO 10993-1, -2, -5, -10, -12. No software or electronic components.

Indications for Use

Indicated for use as a disposable, non-sterile, powder-free nitrile glove worn on the examiner's hand or finger to prevent contamination between patient and examiner in medical settings. Suitable for over-the-counter use.

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

• Blue Nitrile Examination Gloves Powder Free (K192333)

Submission Summary (Full Text)

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April 9, 2022

Watchtower PPE Supplies Inc. % Rafi Wong Manager Pacific Fortune Management Inc. 2350 Mission College Blvd. Ste 475 Santa Clara, California 95054

Re: K212929

Trade/Device Name: Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: March 15, 2022 Received: March 16, 2022

Dear Rafi Wong:

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

Sincerely,

Bifeng Qian, M.D., Ph.D. Acting Assistant Director 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

K212929

Device Name Nitrile Examination Gloves

Indications for Use (Describe)

A powder free 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. The device is for over-the-counter use.

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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# 510K SUMMARY K212929

#### Date of Summary Prepared: March 15, 2022

#### 510K Number: K212929

#### 1. Submitter Information

Submitter Contact:

Address:

# WATCHTOWER PPE SUPPLIES, INC. 600 W John Street, Ste 140B, Hicksville, New York 11801, USA

### Submitter Contact Person:

| Name: | Riva Zheng |
|---------------|------------------------------|
| Phone Number: | ([phone] |
| Email: | [e-mail] |

| | Designated Submission Correspondent: | |
|--|--------------------------------------|--|
| | | |

| Name: | Rafi Wong |
|---------------|--------------------------|
| Phone Number: | [phone] |
| Email: | [e-mail] |

- 2. Device Name: Nitrile Examination Gloves
# 3. Regulatory Information

| Common Name: | Polymer Patient Examination Glove |
|-------------------------|-----------------------------------|
| Apparel Classification: | Class I |
| Product Code: | LZA |
| Regulation Number: | 21 CFR 880.6250 |

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# 4. Predicate Device

| 510K Number: | K192333 |
|---------------|----------------------------------------------------|
| Company name: | JR Engineering & Medical Technologies (M) SDN.BHD. |
| Device Name: | Blue Nitrile Examination Gloves Powder Free |
| Cleared date: | January 24, 2020 |

#### 5. Intended Use/Indications for Use

A powder free 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. The device is for over-the-counter use.

#### Device Description 6.

The proposed Nitrile Examination Gloves are ambidextrous, non-sterile, powder-free, Not made with natural rubber latex and is made of nitrile (Butyronitrile latex) . It has a finger textured surface and is colored blue. This is a single use, disposable device(s), provided non-sterile. The device is provided in 4 sizes, from small to extra-large.

# 7. Summary of Comparison and Technological Characteristics

| Characteristics | Acceptance<br>Criteria | Proposed Device<br>Nitrile<br>Examination<br>Gloves | Predicate Device<br>Blue Nitrile<br>Examination<br>Gloves Powder<br>Free | Comparison |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510K Number | / | K212929 | K192333 | - |
| Product Code | LZA | LZA | LZA | Same |
| Manufacturer | / | WATCHTOWER<br>PPE SUPPLIES,<br>INC. | JR Engineering &<br>Medical<br>Technologies (M)<br>SDN.BHD. | Different |
| Classification | Class I (21 CFR<br>880.6250) | Class I (21 CFR<br>880.6250) | Class I (21 CFR<br>880.6250) | Same |
| | | | | |
| Intended Use /<br>Indications for Use | A patient<br>examination<br>glove is a<br>disposable<br>device intended<br>for medical<br>purposes that is<br>worn on the<br>examiner's hands<br>or fingers to<br>prevent<br>contamination<br>between patient<br>and examiner.<br>The device is for<br>over- the-counter<br>use. | A powder free<br>patient<br>examination<br>glove is a<br>disposable device<br>intended for<br>medical purposes<br>that is worn on<br>the examiner's<br>hand or finger to<br>prevent<br>contamination<br>between patient<br>and examiner.<br>The device is for<br>over-the-counter<br>use. | A powder free<br>patient examination<br>gloves is a<br>disposable device<br>intended for<br>medical purposes<br>that is worn on the<br>examiner's hand or<br>finger to prevent<br>contamination<br>between patient and<br>examiner. | Same |
| Material Use | Nitrile | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Blue | Same |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Same |
| Dimensions<br>(ASTM<br>D6319- 19) | Overall<br>Length<br>(mm) 220<br>mm = (sizes<br>XS-S)<br>230 mm =<br>(sizes M-<br>XL)<br>Width (±10<br>mm) Size S =<br>80 mm Size<br>M = 95 mm<br>Size L = 110<br>mm Size XL<br>= 120 mm<br>Thickness at<br>Finger<br>(mm)<br>All Sizes =<br>0.05mm<br>Thickness at<br>Palm<br>(mm) | Size: M<br>Length Min:<br>230mm Palm<br>Width Min: 95<br>+/-10mm<br>Finger<br>Thickness min:<br>0.05 mm Palm<br>Thickness<br>min: 0.05 mm | Size: M<br>Length<br>Min:<br>230mm<br>Palm Width Min:<br>95+/-10mm<br>Finger Thickness<br>min: 0.05 mm<br>Palm Thickness<br>min: 0.05 mm | Same |
| | All Sizes =<br>0.05mm | | | |
| | Before Aging ASTM D6319-19 | | | |
| Physical<br>Properties | Tensile<br>Strength<br>(MPa) = 14<br>min. | Tensile Strength<br>(Mpa)<br>$≥$ 14 min. | Tensile Strength<br>(Mpa) = 14 min. | Same |
| | Ultimate<br>Elongation<br>(%) = 500<br>min. | Ultimate<br>Elongation<br>(%) 500 min. | Ultimate<br>Elongation (%)<br>= 500 min. | Same |
| | After Aging ASTM D6319-19 | | | |
| | Tensile<br>Strength<br>(Mpa) = 14<br>min. | Tensile Strength<br>(Mpa)<br>$≥$ 14 min. | Tensile<br>Strength (Mpa)<br>$≥$ 14 min. | Same |
| | Ultimate<br>Elongation<br>(%) = 400<br>min. | Ultimate<br>Elongation<br>(%) 400 min. | Ultimate<br>Elongation<br>(%) 400 min. | Same |
| Freedom from<br>Holes<br>(ASTM D5151) | AQL 2.5<br>Inspection<br>Level G-1 | Passes AQL-2.5 | Passes AQL-2.5 | Same |
| Residual<br>Power (ASTM<br>D6124) | $≤$ 2.0 mg/pc | $≤$ 2.0 mg/pc | $≤$ 2.0 mg/pc | Same |
| | Primary Skin<br>Irritation Test<br>ISO 10993-<br>10 | Under the<br>conditions of<br>study, the test<br>article showed no<br>irritation<br>on the skin. | Under the condition<br>of study not an<br>irritant. | Same |
| Biocompatibility | Dermal<br>Sensitization<br>Assay<br>ISO 10993-<br>10 | Under the<br>conditions of<br>study, there is no<br>evidence that the<br>test article<br>extracts would<br>cause<br>sensitization on<br>guinea pig. | Under the<br>conditions of the<br>study not a<br>sensitizer. | Same |
| | In Vitro<br>Cytotoxicity<br>ISO 10993-5 | Under the<br>conditions of this<br>study,the MEM<br>test extracts<br>would be<br>considered<br>cytotoxic<br>potential. | Under the<br>conditions of the<br>study, cytotoxic.<br>Additional testing<br>was performed to<br>determine if this<br>was a systemic<br>toxicity concern. | Same |
| | Acute<br>Systemic<br>Cytotoxicity<br>ISO<br>10993-11 | Under the<br>conditions of this<br>study, there is no<br>mortality or<br>evidence of<br>systemic toxicity<br>from the extracts.<br>The test met the<br>test requirements. | Under the condition<br>of the study the<br>device extracts do<br>not pose a systemic<br>toxicity concern. | Same |
| | Material<br>Mediated<br>Pyrogenicity<br>ISO 10993-<br>11 | Under the<br>conditions of this<br>study, the test<br>article would be<br>considered no<br>febrile reaction.<br>The test article<br>meets the test<br>requirements. | Not performed | N/A |

#### Table I - General Comparison

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### 8. Non-clinical Tests Performed on the Proposed Device

The proposed device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Medical Glove Guidance Manual Document, issued on January 22, 2008

### STANDARDS:

- ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical ● Application
- . ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6124-06/(R)2017 Standard Test Method for Residual Powder on Medical Gloves
- . 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
- ISO 10993- 1: 2009/(R)2013 Biological Evaluation of Medical Devices- Part 1: Evaluation . and testing within a risk management process
- . ISO 10993-2:2006/(R)2014 Biological Evaluation of medical devices - Part 2: Animal welfare requirements
- . ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

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| Test Method | Purpose | Acceptance Criteria | Results | | |
|---------------|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|------------------|
| ASTM D6319-19 | Physical<br>Dimensions<br>Test | Length(mm):<br>S:≥220;<br>M/L/XL:≥230;<br>Width(mm):<br>S: 80±10;<br>M: 95±10;<br>L: 110±10;<br>XL: 120±10<br>Thickness (mm):<br>Finger: ≥0.05<br>Palm: ≥0.05 | Length(mm): >240/Pass;<br>Width(mm):<br>S: 87-88/Pass<br>M: 96-97/ Pass<br>L: 110/ Pass;<br>XL:114-115/ Pass<br>Thickness (mm):<br>S:<br>Finger: 0.115-0.123/Pass<br>Palm: 0.066-0.073/Pass<br>M:<br>Finger: 0.120-0.132/Pass<br>Palm: 0.067-0.075/Pass<br>L:<br>Finger: 0.118-0.125/Pass<br>Palm: 0.069-0.073/Pass<br>XL:<br>Finger: 0.113-0.120/Pass<br>Palm: 0.068-0.072/Pass | | |
| | | | | | |
| | Physical properties | Before<br>Aging | Tensile<br>Strength | ≥14MPa | 30.7-38 MPa/Pass |
| | | Before<br>Aging | Ultimate<br>Elongation | ≥500% | 500-525%/Pass |
| | | After<br>Aging | Tensile<br>Strength | ≥14MPa | 22.4-41 MPa/Pass |
| | | After<br>Aging | Ultimate<br>Elongation | ≥400% | 457-516%/Pass |

# Table II. Summary of Non-Clinical Performance Testing

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| ASTM D5151-19 | Watertightness<br>Test for Detection<br>of Holes | Meet the requirements of<br>ASTM D5151<br>AQL 2.5 | 0/200/Pass |
|---------------------------|----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM D6124-<br>06/(R)2017 | Powder Content | Meet the requirements of<br>ASTM D6124 < 2.0mg | 0.1mg/Pass; |
| ISO 10993-10:<br>2010 | Irritation | Non-irritating | Under the conditions of the study,<br>not anirritant/ Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study,<br>not a sensitizer./ Pass |
| ISO 10993-11 | To evaluate the<br>potential for<br>medical device<br>materials to cause<br>adverse systemic<br>reactions | Non- systemic<br>toxicity | Under conditions of the study,<br>There was no evidence of systemic<br>toxicity from the extract / Pass |
| ISO 10993-5 | This part of ISO<br>10993 describes<br>test methods to<br>assess the in vitro<br>cytotoxicity of<br>medical devices. | The viab.% of the<br>100% extract of the<br>test article is the final<br>result, and if viability is<br>reduced to <70% of<br>the blank, it has<br>cytotoxic potential | Viab.% of 100% test article extract<br>is 9.87%<br>It means the proposed device have<br>potential toxicity to L-929 in the<br>MTT method/ Pass |

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### 9. Clinical Test

There is no clinical study included in this submission.

## 10. Conclusion

The conclusions drawn from the non-clinical tests demonstrate that the proposed device Nitrile Examination Gloves are as safe, as effective, and performs as well as or better than the predicate device, Blue Nitrile Examination Gloves Powder Free (K192333) manufactured by JR Engineering & Medical Technologies (M) SDN.BHD.