Proclean - Nitrile Powder Free Examination Gloves

K211374 · Dr.Boo Company Limited · LZA · Oct 13, 2021 · General Hospital

Device Facts

• Record ID: K211374
• Device Name: Proclean - Nitrile Powder Free Examination Gloves
• Applicant: Dr.Boo Company Limited
• Product Code: LZA · General Hospital
• Decision Date: Oct 13, 2021
• 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.

Device Story

Proclean Nitrile Powder Free Examination Gloves are disposable, single-use patient examination gloves. Made from acrylonitrile-butadiene copolymer dispersion, these blue, powder-free gloves are worn by healthcare examiners on their hands or fingers. The primary function is to serve as a protective barrier to prevent contamination between the patient and the examiner during medical procedures. The device is used in clinical settings by healthcare professionals. The gloves are manufactured in various sizes (Extra Small to Extra Large) and feature textured fingers to assist with grip. They are designed to meet established physical property and biocompatibility standards, ensuring safety and effectiveness as a barrier device.

Clinical Evidence

No clinical data. Bench testing only, including physical properties (tensile strength, elongation), dimensions, watertight testing (ASTM D5151-19), residual powder (ASTM D6124-06), and biocompatibility (ISO 10993-5, -10, -11).

Technological Characteristics

Material: Acrylonitrile-butadiene copolymer (Nitrile/NBR) per ASTM D6319-19. Form factor: Disposable, powder-free, blue, textured fingers. Sizes: XS-XL. Sterilization: Not specified. Connectivity: None. Software: None.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent cross-contamination between patient and examiner.

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

• Palm Care Blue Nitrile Examination Gloves Powder Free (K202384)

Submission Summary (Full Text)

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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 and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 13, 2021

Dr.Boo Company Limited Darunee Varabuntoonvit Marketing Director 662/1-4 Moo 3 Phanomsarakarm-Sattahip Rd, Kaokansong Sriracha. Chonburi 20110 Thailand

Re: K211374

Trade/Device Name: Proclean - Nitrile Powder Free Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: July 30, 2021 Received: September 7, 2021

Dear Darunee Varabuntoonvit:

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

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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,

For Clarence W. Murray, III, PhD 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

#### 510(k) Number (if known) K211374

Device Name

PRO CLEAN - NITRILE POWDER FREE 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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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Image /page/3/Picture/0 description: The image is a logo for Dr. BOO, a company that has been around since 1988. The logo features a hand with the words "Dr. BOO" written in the palm. The logo is blue and white, and it has a clean, modern design. The text "Since 1988" is written below the logo.

662/1-4 Moo 3 Phanomsarakarm-Sattahip Rd., Kaokansong, Sriracha, Chonburi, 20110 Thailand Tel: [phone] Fax: [phone] Email: [e-mail] Website: www.drboo.co.th

# 510(k) SUMMARY Nitrile Powder Free Examination Gloves

## 1.0 Appliance Information

| Applicant:<br>Address: | Dr.Boo Company Limited<br>662/1-4 Moo 3 Phanomsarakarm-Sattahip Rd,<br>Kaokansong, Sriracha. Chonburi, 20110 Thailand |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| Email: | [e-mail] |
| Name of Contact Person: | Ms. Darunee Varabuntoonvit |
| Designation: | Marketing Director |
| Contact Number: | [phone] |
| Contact Email: | [e-mail] |
| Date 510(k) summary prepared: | July 30, 2021 |

## 2.0 Identification of the subject device

| Trade/Proprietary Name(s): | PROCLEAN - NITRILE POWDER FREE EXAMINATION GLOVES |
|----------------------------|---------------------------------------------------|
| Common Name: | Nitrile Powder Free Examination Gloves |
| Classification Name: | Patient Examination Gloves |
| Device Class: | I |
| product code | LZA |
| Regulation Number: | 21 CFR 880.6250 |
| Review Panel: | General Hospital |

## 3.0 Predicate Device

| Device Name: | Palm Care Blue Nitrile Examination Gloves Powder Free |
|-----------------------|-------------------------------------------------------|
| 510(k): | K202384 |
| Common Name: | Patient Examination Gloves |
| Classification Name: | Patient Examination Gloves |
| Device Classification | I |
| Product Code: | LZA |
| Regulation Number: | 21 CFR 880.6250 |

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Image /page/4/Picture/0 description: The image is a logo for "Dr. BOO" and includes a hand graphic. The hand is in a light blue color and is positioned behind the text "Dr. BOO". The text is also in light blue and is inside of a circle. Below the logo, the text "Since 1988" is displayed.

### DR.BOO COMPANY LIMITED 662/1-4 Moo 3 Phanomsarakarm-Sattahip Rd., Kaokansong, Sriracha, Chonburi, 20110 Thailand Tel: [phone] Fax: [phone]

Email: [e-mail] Website: www.drboo.co.th

## 4.0 Description of the Device

Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.

## 5.0 Indication for Use of the Device

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.

## 6.0 Summary of Technological Characteristics of the Device Compared to the Predicate Device

| Characteristics | Standards | Device performance | | Comparison |
|--------------------|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | | Predicate | Current | |
| 510(k) Number | - | K202384 | New 510(k) submission | ---- |
| Manufacturer(s) | - | Hi-Care Thai Gloves Co. Ltd | Dr. Boo Company Limited | ---- |
| Name of device | - | Blue Nitrile<br>Examination Gloves<br>Powder free | Blue Nitrile<br>Examination Gloves<br>Powder free | ---- |
| Indication for Use | Medical Gloves<br>Guidance Manual -<br>Issued on January<br>22, 2008 | Blue Nitrile<br>Examination Gloves<br>Powder-free is disposable<br>devices intended for medical<br>purpose that are won on the<br>examiner's hand to prevent<br>contamination<br>between<br>patient and examiner | A powder-free patient<br>Examination Gloves is a<br>disposable device intended<br>for medical purposes that is<br>worn on the examiner's hand<br>or finger to prevent<br>contamination between<br>patient and examiner | Similar |
| Material | ASTM D6319-19 | Nitrile (NBR) | Nitrile (NBR) | Same |
| Color | - | Blue | Blue | Same |
| Texture | - | Textured Fingers | Textured Fingers | Same |
| Size | ASTM D6319-19 | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large | Same |

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Image /page/5/Picture/0 description: The image is a logo for "Dr. BOO" and includes a hand graphic. The hand is teal and is positioned above the text "Dr. BOO" which is inside of a circle. Below the circle is the text "Since 1988" also in teal.

662/1-4 Moo 3 Phanomsarakarm-Sattahip Rd., Kaokansong, Sriracha, Chonburi, 20110 Thailand Tel: [phone] Fax: [phone] Email: [e-mail] Website: www.drboo.co.th

| Characteristics | Standards | Device performance | | Comparison |
|------------------------------|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | | Predicate | Current | |
| Single Use | Medical Gloves<br>Guidance Manual -<br>Issued on January<br>22, 2008<br>-Labeling | Single use | Single use | Same |
| Dimension | ASTM D6319-19 | Meet ASTM D6319-19<br>Length 230 mm min.<br>Width 95 ± 10 mm min<br>(for Medium size) | Meet ASTM D6319-19<br>Length 230 mm min.<br>Width 95 ± 10 mm min<br>(for Medium size) | Same |
| Thickness | ASTM D6319-19 | Meet ASTM D6319-19<br>Finger: 0.05 mm min<br>Palm: 0.05 mm min | Meet ASTM D6319-19<br>Finger: 0.05 mm min<br>Palm: 0.05 mm min | Same |
| Physical<br>Properties | ASTM D6319-19 | Meet ASTM D6319-19<br><b>Before aging</b><br>Tensile Strength:<br>14 MPa min<br>Ultimate Elongation:<br>500% min<br><b>After aging</b><br>Tensile Strength<br>14 MPa min<br>Ultimate Elongation:<br>400% min | Meet ASTM D6319-19<br><b>Before aging</b><br>Tensile Strength:<br>14 MPa min<br>Ultimate Elongation:<br>500% min<br><b>After aging</b><br>Tensile Strength<br>14 MPa min<br>Ultimate Elongation:<br>400% min | Same |
| Watertight test<br>(1000 ml) | ASTM D5151-19 | Pass AQL 1.5 | Pass AQL 1.5 | Similar |
| Powder Residue | ASTM D6124-06<br>(Reapproved 2017) | Meet<br>≤ 2.0 mg/glove | Meet<br>≤ 2.0 mg/glove | Similar |

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Image /page/6/Picture/0 description: The image is a logo for "Dr. BOO" and it includes a hand graphic. The hand is in the background and the text "Dr. BOO" is in a circle in front of the hand. The text "Since 1988" is at the bottom of the image.

662/1-4 Moo 3 Phanomsarakarm-Sattahip Rd., Kaokansong, Sriracha, Chonburi, 20110 Thailand Tel: [phone] Fax: [phone] Email: [e-mail] Website: www.drboo.co.th

| Characteristics | Standards | Device performance | | |
|------------------|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|------------|
| | | Predicate | Current | Comparison |
| Biocompatibility | Primary Skin<br>Irritation -<br>ISO 10993-10 Third<br>Edition 2010-08-01 | Under the conditions<br>of the study, not an<br>irritant | Under the conditions<br>of the study, not an<br>irritant | Same |
| | Dermal<br>Sensitization -<br>ISO 10993-10 Third<br>Edition 2010-08-01 | Under the conditions<br>of the study, not a<br>sensitizer | Under the conditions<br>of the study, not a<br>sensitizer | Same |
| | In vitro cytotoxicity<br>ISO10993-5<br>:2009(E) | Under the conditions<br>of the study, noncytotoxic | Under the conditions<br>of the study, non-cytotoxic | Same |
| | Acute Systemic<br>Toxicity ISO10993-<br>11:2017(E) | Under the conditions of<br>study, the device extracts do<br>not pose a systemic toxicity<br>concern | Under the conditions of the<br>study, did not induce any<br>systemic toxicity. | Same |

There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods. Both devices meet the ASTM standards.

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Image /page/7/Picture/0 description: The image is a logo for "Dr. BOO" and includes a hand with a circle around the brand name. The text "Since 1988" is located below the logo. The logo is a light blue color and has a clean, modern design.

662/1-4 Moo 3 Phanomsarakarm-Sattahip Rd., Kaokansong, Sriracha, Chonburi, 20110 Thailand Tel: [phone] Fax: [phone] Email: [e-mail] Website: www.drboo.co.th

#### 7.0 Non-clinical testing summary

Performance Data

| Test Method | Standard | Purpose of testing | Acceptance Criteria | Result | Status |
|------------------------|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| | ASTM D6319-19<br>Standard Specification for Nitrile<br>Examination Gloves for Medical<br>Application | To determine the length<br>of the gloves | Min 230 mm for all sizes | Extra Small: 230 mm<br>Small: 230 mm<br>Medium: 240 mm<br>Large: 236 mm<br>Extra Large: 236 mm | Pass |
| Dimension | ASTM D6319-19<br>Standard Specification for Nitrile<br>Examination Gloves for Medical<br>Application | To determine the width<br>of the gloves | Extra Small: 70 $\pm$ 10 mm<br>Small: 80 $\pm$ 10 mm<br>Medium: 95 $\pm$ 10 mm<br>Large: 110 $\pm$ 10 mm<br>Extra Large: 120 $\pm$ 10 mm | Extra Small: 68mm<br>Small: 79 mm<br>Medium: 96 mm<br>Large: 110 mm<br>Extra Large: 120 mm | Pass |
| | ASTM D6319-19<br>Standard Specification for Nitrile<br>Examination Gloves for Medical<br>Application | To determine the<br>thickness of the gloves | Palm 0.05 mm min<br>Finger 0.05 mm min for all sizes | Extra Small: Palm 0.11 mm, Finger: 0.11 mm<br>Small: Palm 0.09 mm, Finger: 0.10 mm<br>Medium: Palm: 0.08 mm, Finger: 0.08 mm<br>Large: Palm 0.10 mm, Finger: 0.11 mm<br>Extra Large: Palm 0.10 mm, Finger: 0.11 mm | Pass |
| Test Method | Standard | Purpose of testing | Acceptance Criteria | Result | Status |
| Watertight test | ASTM D5151-19<br>Standard Test Method for Detection<br>of Holes in Medical<br>Gloves | To determine the holes in<br>the gloves | Sample size: 200 pcs<br>Inspection level : Gl<br>AQL 1.5<br>Acceptance Number 7<br>Rejection Number 8 | The batch size for this sampling is<br>35,001-150,000. Hence, according to the<br>single sampling plan GI, the sample to be<br>drawn is under code L equivalent to 200<br>pcs with accept 7 and reject 8 to be<br>accept under AQL 1.5<br>Extra Small: : 0 (Zero)<br>Small: 0 (Zero)<br>Medium: 0 (Zero)<br>Large:0 (Zero)<br>Extra Large:0 (Zero). | Pass |
| Residual<br>powder | ASTM D6124-06 (Reapproved 2017)<br>Standard Test Method for Residual<br>Powder on Medical Gloves | To determine the residual<br>powder in the gloves | 2 mg per glove or less | Sample size : 5 pcs<br>Requirement: 2 mg per glove or less<br>Result<br>Extra Small: 1.35 mg/glove<br>Small:1.35 mg/glove<br>Medium: 0.50 mg/glove<br>Large: 1.34 mg/glove<br>Extra Large:1.36 mg/glove | Pass |
| Physical<br>Properties | ASTM D6319-19<br>Standard Specification for Nitrile<br>Examination Gloves for Medical<br>Application | To Determine the<br>physical properties-<br>Tensile strength | Before Ageing<br>Tensile Strength 14Mpa<br>Minimal for all sizes<br>After Ageing Tensile<br>Strength 14Mpa<br>Minimal for all sizes | Before Ageing<br>Extra Small: 18.08 MPa<br>Small: 18.37 MPa<br>Medium: 35.52 MPa<br>Large: 18.30 MPa<br>Extra Large: 18.20 MPa<br>After Ageing:<br>Extra Small: 14.01 MPa<br>Small: 14.08 MPa<br>Medium: 34.50 MPa<br>Large: 14.00 MPa<br>Extra Large: 14.00 MPa | Pass |
| Test Method | Standard | Purpose of testing | Acceptance Criteria | Result | Status |
| Physical<br>Properties | ASTM D6319-19<br>Standard Specification for Nitrile<br>Examination Gloves for Medical<br>Application | To Determine the<br>physical properties-<br>Ultimate Elongation | Before Ageing<br>Ultimate Elongation<br>500% Min for all sizes<br><br>After Ageing Ultimate<br>Elongation 400% Min<br>for all sizes | Before Ageing:<br>Extra Small: 611 %<br>Small: 612%<br>Medium: 601 %<br>Large:620%<br>Extra Large:587%<br><br>After Ageing:<br>Extra Small: 412 %<br>Small:408%<br>Medium: 529%<br>Large:403%<br>Extra Large:416% | Pass |

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Image /page/8/Picture/0 description: The image is a logo for Dr. BOO, a company that has been around since 1998. The logo is a square with rounded corners, and it features a hand with the fingers spread apart. The text "Dr. BOO" is written in a bold, sans-serif font inside of a circle. The text "Since 1998" is written below the square.

662/1-4 Moo 3 Phanomsarakarm-Sattahip Rd., Kaokansong, Sriracha, Chonburi, 20110 Thailand Tel: [phone] Fax: [phone] Email: [e-mail] Website: www.drboo.co.th

Since 1988

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Image /page/9/Picture/0 description: The image is a logo for "Dr. BOO". The logo is a square with rounded corners, and it is colored in a light blue. Inside the square is a hand with the words "Dr. BOO" written on top of it. The hand is also colored in light blue.

662/1-4 Moo 3 Phanomsarakarm-Sattahip Rd., Kaokansong, Sriracha, Chonburi, 20110 Thailand Tel: [phone] Fax: [phone] Email: [e-mail] Website: www.drboo.co.th

Since 1988

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Image /page/10/Picture/0 description: The image is a logo for "Dr. BOO" and includes a hand graphic. The hand is white with a blue outline and is positioned inside of a blue circle. The text "Dr. BOO" is in blue and is located in the center of the circle. Below the circle, the text "Since 1988" is written in blue.

662/1-4 Moo 3 Phanomsarakarm-Sattahip Rd., Kaokansong, Sriracha, Chonburi, 20110 Thailand Tel: [phone] Fax: [phone] Email: [e-mail] Website: www.drboo.co.th

## 8.0 Clinical Testing Summary

Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

## 9.0 Conclusion

The conclusions drawn from the non-clinical test demonstrate that the subject device Nitrile Powder Free Examination Glove is as safe, as effective, and performs as well as or better than the legally marketed predicate device K202384.