Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)
Device Facts
| Record ID | K192635 |
|---|---|
| Device Name | Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange) |
| Applicant | Wrp Asia Pacific Sdn. Bhd. |
| Product Code | LZA · General Hospital |
| Decision Date | Jan 17, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
Intended Use
A 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
Disposable nitrile patient examination glove; non-sterile; orange color; hand-textured surface. Manufactured from synthetic rubber; surface treatment applied to facilitate donning without powder. Ambidextrous design. Used in clinical settings by healthcare professionals to provide a barrier against contamination between patient and examiner. Device acts as a physical barrier; performance verified against ASTM D6319-10 standards for physical properties and watertight integrity. Benefits include protection against cross-contamination during medical examinations.
Clinical Evidence
No clinical data included. Bench testing only, including physical properties (tensile strength, elongation), dimensions, watertight integrity (ASTM D5151-06), residual powder (ASTM D6124-06), and biocompatibility (primary skin irritation, dermal sensitization, acute systemic toxicity).
Technological Characteristics
Material: Nitrile synthetic rubber. Form factor: Ambidextrous, hand-textured, orange. Thickness: 0.19-0.23mm (finger/palm). Standards: ASTM D6319-10 (physical properties/dimensions), ASTM D5151-06 (watertight), ASTM D6124-06 (residual powder). Biocompatibility: ISO 10993-10 (irritation/sensitization), ISO 10993-11 (acute systemic toxicity). Non-sterile.
Indications for Use
Indicated for use as a disposable medical device worn on the examiner's hand or finger to prevent 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
- Dermagrip Powder Free Blue Nitrile Examination Gloves (K133168)
Related Devices
- K223895 — Disposable Medical Nitrile Examination Gloves · Hebei Titans Hongsen Medical Technology Co., Ltd. · Mar 23, 2023
- K133168 — DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE · Wrp Asia Pacific Sdn. Bhd. · Aug 7, 2014
- K212916 — Black Nitrile Powder Free Patient Examination Glove, Non Sterile · Rimba Glove Sdn Bhd · Mar 24, 2022
- K210755 — Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) · Meditech Gloves Sdn Bhd · May 7, 2021
- K153708 — Halyard Black-Orange Powder-Free Nitrile Exam Glove · Halyard Health · Mar 31, 2016
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains 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.
January 17, 2020
Wrp Asia Pacific Sdn Bhd Hasnah Hamid Quality Assurance Manager Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi Sepang, 43900 My
Re: K192635
Trade/Device Name: Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: October 24, 2019 Received: October 28, 2019
Dear Hasnah Hamid:
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/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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Elizabeth Claverie, M.S. 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
{2}------------------------------------------------
### Indications for Use
510(k) Number (if known) K192635
Device Name
Powder Free Nitrile Patient Examination Glove, Non-Sterile (Orange)
Indications for Use (Describe)
A 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)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
### *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:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
#### 1.0 Submitter:
| Name: | Hasnah Abdul Hamid |
|------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | WRP Asia Pacific Sdn Bhd<br>Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi,<br>43900 Sepang, Selangor Darul Ehsan, MALAYSIA |
| Phone No.: | +60 3 8706 1486 |
| Fax No.: | +60 3 8706 1485 |
Date of Summary Prepared: 10th January 2020
#### 2.0 I dentification of the subject device:
Trade Name: Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange) Common Name: Patient Examination Gloves Classification Name: Patient Examination Gloves Device Classification: I Regulation Number: 21 CFR 880.6250 Product Code: LZA
#### 3.0 Predicate Device:
### K133168
Dermagrip Powder Free Blue Nitrile Examination Gloves WRP Asia Pacific Sdn Bhd
#### Description of The Device: 4.0
Powder Free Nitrile Patient Examination Glove, Non-Sterile (Orange) meet all the requirements of ASTM standard D6319-10 and FDA 21 CFR 880.6250.
The powder free nitrile examination qlove is manufactured from synthetic rubber Inner surface of gloves undergo surface treatment process to produce a latex. smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand.
#### 5.0 Indication for Use:
A 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.
{4}------------------------------------------------
### 6.0 Summary of the Technological Characteristics of the Device:
The Powder Free Nitrile Examination Gloves, Non-Sterile (Orange) are summarized with the following technological characteristics compared to ASTM D6319 or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON<br>ANALYSIS |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| | | PREDICATE<br>BLUE | CURRRENT<br>ORANGE | |
| 510(k) Number | - | K133168 | K192635 | Not Available |
| Manufacturer(s) | - | WRP Asia Pacific Sdn Bhd | WRP Asia Pacific Sdn Bhd | Same |
| Material | ASTM D6319-10 | Nitrile | Nitrile | Same |
| Color | - | Blue | Orange | Different |
| Texture | - | Finger textured<br>(Textured only at the finger<br>part) | Hand textured<br>(Fully textured surface from<br>fingertips to end of palm) | Different |
| Physical Properties | ASTM D6319-10 | | | |
| Before Aging | | | | |
| Tensile Strength : | | 14MPa min | 14MPa min | Same |
| Ultimate Elongation : | | 500% min | 500% min | |
| After Aging | | | | |
| Tensile Strength : | | 14MPa min | 14MPa min | Same |
| Ultimate Elongation : | | 400% min | 400% min | |
| Thickness - Finger | ASTM D6319-10 | 0.07-0.10mm | 0.21–0.23mm | Different |
| - Palm | | 0.07-0.09mm | 0.19-0.22mm | |
| - Cuff | | 0.06-0.08mm | 0.10-0.12mm | |
| Powder Free | ASTM D6124-06 | ≤ 2 mg/glove | ≤ 2 mg/glove | Same |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON ANALYSIS |
| | | PREDICATE BLUE | CURRRENT ORANGE | |
| Biocompatibility | Primary Skin Irritation -<br>ISO 10993-10:2002(E)<br>&<br>Consumer Product<br>Safety Commission,<br>Title 16, Chapter II, Part<br>1500 | Passes (Not a primary skin<br>irritant)<br>There was no erythema or<br>oedema noted on test site<br>after (24±2), (48±2) and<br>(72±2) hours. The primary<br>Irritation Index (PII) was "0" | Passes (Not a primary skin irritant)<br>There was no erythema or oedema<br>noted on test site after (24±2), (48±2)<br>and (72±2) hours. The primary<br>Irritation Index (PII) was "0" | Similar |
| Biocompatibility | Dermal Sensitization-<br>ISO 10993-10:2002 (E)<br>& Consumer Product<br>Safety Commission,<br>Title 16, Chapter II, Part<br>1500.3 (c) (4) | Passes (Not a contact<br>sensitizer)<br>There was no positive allergic<br>reaction observed during the<br>challenge phase (at 24 hours<br>and 48 hours) in animals<br>treated with the test material<br>and negative control. | Passes (Not a contact sensitizer)<br>There was no positive allergic reaction<br>observed during the challenge phase<br>(at 0, 24 hours and 48 hours) in<br>animals treated with the test material<br>and negative control. | Similar |
| Biocompatibility | Cytotoxicity — MEM<br>Elution,<br>ISO 10993-5:2009 (E) | Not available. | Exhibit severe cytotoxicity reactivity at<br>100%, 66%, and 44% extract<br>concentration.<br>Moderate cytotoxicity reactivity at<br>30%, mild cytotoxicity reactivity at<br>20% and slight cytotoxicity reactivity<br>at 15% extract concentrations.<br>Cytotoxicity concern was<br>addressed by acute systematic<br>toxicity testing. | Different |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON ANALYSIS |
| | | PREDICATE<br>BLUE | CURRENT<br>ORANGE | |
| Biocompatibility | Acute Systemic Toxicity,<br>ISO 10993-11:2017 (E) | Not Available | It is concluded that the<br>extracts (polar and non -<br>polar) of the product did not<br>show any systemic toxicity. | Different |
| Watertight (1000ml) | ASTM D5151-06 | Inspection<br>Level 1, AQL 1.5 | Inspection<br>Level 1, AQL 1.5 | Same |
| Intended use | | A patient examination glove is<br>a disposable device intended<br>for medical purposes that is<br>worn on the examiner's hand<br>or finger to prevent<br>contamination between patient<br>and examiner. | A patient examination glove<br>is a disposable device<br>intended for medical purposes<br>that is worn on the<br>examiner's hand or finger to<br>prevent contamination<br>between patient and<br>examiner. | Same |
| Size | Medical Glove Guidance<br>Manual - Labeling | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large | Similar |
| Single Use | Medical Glove Guidance<br>Manual - Labeling | Single use | Single use | Same |
{5}------------------------------------------------
{6}------------------------------------------------
{7}------------------------------------------------
There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods except for color and thickness. The current device is orange in color and thicker than predicate device.
### 7.0 Summary of Non-Clinical Testing
The performance test data of the non-clinical tests for this powder free nitrile examination glove is summarized as per below.
{8}------------------------------------------------
| Test<br>Method | Standard | Purpose of Testing | Acceptance Criteria | | Results | | Status |
|------------------------|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|---------------------|-----------------|-----------------------|-----------------------|--------|
| Physical<br>Properties | ASTM D412-16<br>(Standard Test<br>Method for<br>Vulcanized Rubber<br>and Thermoplastic<br>Elastomers-Tension) | To evaluate the<br>tensile (tension)<br>properties of glove. | Before<br>aging | After<br>aging | Before<br>aging | After<br>aging | |
| | | | Min 14.0<br>MPa | Min 14.0<br>MPa | 24.5 MPa<br>(Average) | 26.4 MPa<br>(Average) | Pass |
| | | | Min<br>500% | Min<br>400% | 547% | 449% | Pass |
| Test<br>Method | Standard | Purpose of<br>Testing | Acceptance Criteria | Results | Status |
|----------------|----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|--------|
| Dimension | ASTM D3767 -<br>03(2014)<br>Standard Practice<br>for Rubber—<br>Measurement of<br>Dimensions | To measure the<br>length, width<br>and thickness of<br>glove | Length<br>Min 240 mm | Length<br>Min 242 mm | Pass |
| | | | Width<br>Min 95 ± 10 mm | Width<br>95 mm | Pass |
| | | | Thickness<br>Finger – 0.05 mm<br>Palm – 0.05 mm | Thickness<br>Finger – 0.22 mm<br>Palm – 0.21 mm | Pass |
| Test<br>Method | Standard | Purpose of<br>Testing | Acceptance Criteria | Results | Status |
| Watertight | ASTM D5151 - 06<br>(Standard Test<br>Method for<br>Detection of Holes in<br>Medical Gloves) | To detect holes<br>that leak water<br>and thereby<br>compromise the<br>usefulness of | Sample size: 315 pcs<br>Inspection level: G1<br>AQL: 1.5, Acceptance No. 10,<br>Found 2 | The batch size for this<br>sampling is 150,001 to<br>500,000. Hence,<br>according to the single | Pass |
{9}------------------------------------------------
| | | the glove. | | sampling plan GI, the<br>sample to be drawn is<br>under code M equivalent<br>to 315 pieces with accept<br>10 and reject 11 to be<br>accepted under AQL 1.5.<br>During the test, 2 pieces<br>were found with leaks.<br>Hence it falls within the<br>acceptance criteria. | |
|--|--|------------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
|--|--|------------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Test<br>Method | Standard | Purpose of<br>Testing | Acceptance Criteria | Results | Status |
|--------------------|----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------|-----------------------------------------------------------------------------|--------|
| Residual<br>Powder | ASTM D6124-06<br>(Standard Test<br>Method for Residual<br>Powder on Medical<br>Gloves) | To determine<br>the amount of<br>residual powder<br>and non-powder<br>solids found on<br>gloves. | Less than 2 mg per glove | Sample size : 5 pcs<br>Requirement : <2mg/glove<br>Result : 1.9 mg/glove | Pass |
{10}------------------------------------------------
### Summary of Clinical Testing 8.0
No clinical study is included in this submission.
### 9.0 Conclusion
The conclusion drawn from the non-clinical test demonstrate that the subject Powder Free Nitrile Patient Examination Glove, Non-Sterile (Orange) is as safe, as effective, and performs as well as or better than the legally marketed predicate device K133168.
