Who is the manufacturer of Black Nitrile Powder Free Patient Examination Glove, Non Sterile?

Safeskin Retailing (Hk) Limited filed the 510(k) submission for Black Nitrile Powder Free Patient Examination Glove, Non Sterile (K222715).

What is the FDA product code for Black Nitrile Powder Free Patient Examination Glove, Non Sterile?

LZA. It is classified under 21 CFR 880.6250 as a Class 1 device in the General Hospital panel.

What is the regulatory pathway for Black Nitrile Powder Free Patient Examination Glove, Non Sterile?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Black Nitrile Powder Free Patient Examination Glove, Non Sterile?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Black Nitrile Powder Free Patient Examination Glove, Non Sterile

K222715 · Safeskin Retailing (Hk) Limited · LZA · Dec 3, 2022 · General Hospital

Device Facts

Record ID	K222715
Device Name	Black Nitrile Powder Free Patient Examination Glove, Non Sterile
Applicant	Safeskin Retailing (Hk) Limited
Product Code	LZA · General Hospital
Decision Date	Dec 3, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6250
Device Class	Class 1

Intended Use

A nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner

Device Story

Disposable, non-sterile, ambidextrous patient examination glove made of nitrile rubber. Designed for use by healthcare professionals in clinical settings to provide a barrier against contamination. Surface treatment ensures smooth donning without powder or silicone lubricants. Device is single-use. Performance verified through physical property testing (tensile strength, elongation), watertight integrity (ASTM D5151), and biocompatibility assessments (irritation, sensitization, systemic toxicity).

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM D412 (tensile/elongation), ASTM D3767 (dimensions), ASTM D5151 (watertight/holes), and ASTM D6124 (residual powder). Biocompatibility testing per ISO 10993-10 (irritation/sensitization) and ISO 10993-11 (acute systemic toxicity) confirmed safety.

Technological Characteristics

Material: Nitrile rubber. Form: Ambidextrous, powder-free, non-sterile. Dimensions/Physicals: Compliant with ASTM D6319. Thickness: 0.06mm (palm) to 0.10mm (finger). Biocompatibility: ISO 10993-10 and ISO 10993-11 compliant. Manufacturing: Surface treatment for smooth donning.

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

Disposable Powder Free Nitrile Examination Glove, Black Color (K190942)

Related Devices

K210755 — Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) · Meditech Gloves Sdn Bhd · May 7, 2021
K140418 — POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE · Wrp Rubber Products Sdn Bhd · Sep 3, 2014
K210684 — Disposable Nitrile Medical Examination Glove · Jiangsu Cureguard Glove Co., Ltd. · Jul 20, 2021
K210366 — Blue Nitrile Powder Free Patient Examination Glove, Non Sterile · Onetexx Sdn Bhd · May 7, 2021
K212916 — Black Nitrile Powder Free Patient Examination Glove, Non Sterile · Rimba Glove Sdn Bhd · Mar 24, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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. December 3, 2022 Safeskin Retailing (HK) Limited % Stephan Toupan President Dawa Medical LLC 7320 NW 12th Street Suite 103 Miami, Florida 33126 Re: K222715 Trade/Device Name: Black Nitrile Powder Free Patient Examination Glove, Non Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA Dated: September 5, 2022 Received: September 8, 2022 Dear Stephan Toupan: 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. {1}------------------------------------------------ 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # Bifeng Qian -S Bifeng Oian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K222715 Device Name BLACK NITRILE POWDER-FREE PATIENT EXAMINATION GLOVE, NON STERILE Indications for Use (Describe) A nitrile patient examination glove is a disposable device made of nitrile rubber 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. 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}------------------------------------------------ # 510(k) Summary K222715 As required by 21CFR§807.92(c) | 1.0 | Submitter: Name | : Alvin Ho | |-----|--------------------------|-----------------------------------------------------------------------------------------------------------------| | | Address | : Safeskin Retailing (HK) Limited 26th Floor, Beautiful Group Tower, 77 Connaught Road Central, Hong Kong | | | Phone No. | : +6012 826 5625 | | | Date of Summary Prepared | : 11 November 2022 | #### 2.0 Identification of the subject device: | Trade Name: | Black Nitrile Powder-Free Patient Examination Glove, Non- Sterile | |-----------------------|----------------------------------------------------------------------| | Common Name: | Patient Examination Gloves | | Classification Name: | Patient Examination Gloves | | Device Classification | 1 | | Regulation Number: | 21 CFR 880.6250 | | Product Code | LZA | #### 3.0 Predicate Device: ## K190942 Trade Name : Disposable Powder Free Nitrile Examination Glove, Black Color Company: Ever Growth (Vietnam) Co., Ltd #### Description of The Subject Device: 4.0 Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile is manufactured from nitrile rubber. Innersurface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder or silicone on the glove surface. The glove is ambidextrous, i.e., can be worn on right or left hand. #### 5.0 Indication for use: A Nitrile 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 Comparison of the Technological Characteristics of the Device: The Black Nitrile Powder-Free Patient Examination Gloves, Non-Sterile are summarized with the following technological characteristics compared to ASTM D6319 or equivalent standards as shown in Table 1 {4}------------------------------------------------ ## Table 1 | | | DEVICE PERFORMANCE | | | |------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------| | CHARACTERISTICS | STANDARDS | PREDICATE BLACK | CURRENT BLACK | COMPARISON ANALYSIS | | 510(k) Number | - | K190942 | K222715 | | | Manufacturer(s) | - | Ever Growth (Vietnam) Co., Ltd | Safeskin Retailing (HK) Limited | | | Material | ASTM D6319 | Nitrile | Nitrile | Same | | Color | - | Black | Black | Same | | Sterility | - | Non-Sterile | Non-Sterile | Same | | Handedness | - | Ambidextrous | Ambidextrous | Same | | Physical Properties Before Aging Tensile Strength: Ultimate Elongation: After Aging Tensile Strength: Ultimate Elongation: | ASTM D6319 | 14Mpa, min 500% min 14Mpa, min 400% min | 27.8 – 33.1 Mpa 530 -600% 31.5 – 35.3 Mpa 470- 550% | Different but within the ASTM standard Different but within the ASTM standard | | Thickness: - Finger - Palm Powder Free | ASTM D6319 ASTM D6124 | 0.05mm min 0.05mm min < 2mg per glove | Min 0.10mm for (XS, S, M, L, XL) Min 0.06mm for (XS, S, M, L, XL) Below 2mg of residual powder | Different but within the ASTM standard Similar | | | STANDARDS | DEVICE PERFORMANCE | | | | CHARACTERISTICS | | PREDICATE BLACK | CURRENT BLACK | COMPARISON ANALYSIS | | | Primary Skin Irritation - ISO 10993-10:2010 (E) & Consumer Product Safety Commission Title 16. Chapter II, Part 1500 | Passes | Under conditions of this study, the test material did not cause an irritant response. The Primary Irritant Response Category is deemed 'Negligible' | Same | | Biocompatibility | Dermal Sensitization- ISO 10993-10: 2010 (E) & Consumer Product Safety Commission, Title 16,Chapter II, Part 1500.3 (c) (4) | Passes | Under conditions of this study,the test material did not produce a skin sensitization effect in the guinea pigs. | Same | | | Cytotoxicity - MEM Elution, ISO 10993-5: 2009 | Passes | The Systemic Toxicity study was conducted as the accepted alternative to the cytotoxic test | Different - but additional test of Acute Systemic Toxicity is conducted and passed | | | Acute Systemic Toxicity, ISO 10993- 11:2017 (E) | Not Tested | Under conditions of this study,the test item did not induce any systemic toxicity in Swiss albino mice. | Different. The subject glove was tested using systemic toxicity test and passed, but the Predicate did not have the test performed | | CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON ANALYSIS | | | | PREDICATE BLACK | CURRENT BLACK | | | Watertight (1000ml) | ASTM D5151:2019 | In accordance with ASTM D6319-10 and ASTM D5141-06 (Reapproved 2011), G-1, AQL 2.5 | Meets • 21 CFR 800.20 • ASTM D6319-10 (Reapproved 2015) Tested in accordance with ASTM D5151 (Reapproved 2015) with acceptable results At an AQL 1.5 | Different, but within ASTM standard; AQL 1.5 is more stringent than AQL 2.5 | | Intended use | - | The Nitrile Powder Free Patient examination glove is a non-sterile disposable device intended for medical purpose that is worn on the examiners hands or finger to prevent contamination between patient and examiner. | A Nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. | Similar | | Size | Medical Glove Guidance Manual - Labeling | Extra Small Small Medium Large X Large | Extra Small Small Medium Large Extra Large | Same | | Single use | Medical Glove Guidance Manual - Labeling | Single Use | Single Use | Same | {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ #### Summary of Non-Clinical Testing 7.0 The performance test data of the non-clinical tests for this powder free nitrile examination glove is summarized as per below. | Test Method | Standard | Purpose of Testing | Acceptance Criteria | | Results | | Status | | |------------------------|---------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|------------------------|-----------------|-----------------|------------------------------------------------------------|------------------------------------------------------------|------| | | | | Before aging | After aging | Before aging | After aging | | | | Physical Properties | ASTM D412 (Standard Test Method for Vulcanized Rubber and Thermoplastic Elastomers-Tension) | To evaluate the tensile (tension) properties of glove. | Tensile strength | Min 14.0 MPa | Min 14.0 MPa | XS – 28.9 S – 27.8 M – 28.7 L – 28.3 XL – 28.0 | XS – 31.7 S – 32.1 M – 32.4 L – 31.9 XL – 31.5 | Pass | | | | | Ultimate elongation | Min 500% | Min 400% | XS – 540 S – 530 M – 560 L – 540 XL – 540 | XS – 480 S – 470 M – 490 L – 480 XL – 490 | Pass | {8}------------------------------------------------ | Test Method | Standard | Purpose of Testing | Glove Size | Acceptance Criteria | Results | Status | |----------------|----------------------------------------------------------------------------------|----------------------------------------------------------|------------------------------------------|-------------------------------------------------------|---------------------------------|--------| | Dimension | ASTM D3767 Standard Practice for Rubber— Measurementof Dimensions | To measure the length, width and thickness ofglove | X-Small | Length Min 240 mm | Length 244 mm | Pass | | | | | | Width $70 \pm 10$ mm | Width 74.0 mm | Pass | | | | | | Thickness Finger – min 0.05mm Palm – min 0.05mm | Thickness 0.10 mm 0.06 mm | Pass | | | | | Small | Length Min 240 mm | Length 245 mm | Pass | | | | | | Width $80 \pm 10$ mm | Width 85.0 mm | Pass | | | | | | Thickness Finger – min 0.05mm Palm – min 0.05mm | Thickness 0.10 mm 0.06 mm | Pass | | | | | Medium | Length Min 240 mm | Length 244 mm | Pass | | | | | | Width $95 \pm 10$ mm | Width 95.0 mm | Pass | | | | | | Thickness Finger – min 0.05mm Palm – min 0.05mm | Thickness 0.10 mm 0.06 mm | Pass | | | | | Large | Length Min 240 mm | Length 243 mm | Pass | | | | | | Width $110 \pm 10$ mm | Width 106 mm | Pass | | | | Thickness | Finger – min 0.05mm Palm - min 0.05mm | Thickness | 0.10 mm 0.06 mm | Pass | | | | Length | Min 240 mm | Length | 242 mm | Pass | | | X-Large | Width | $120 \pm 10$ mm | Width | 117 mm | Pass | | | | Thickness | Finger - min 0.05mm Palm - min 0.05mm | Thickness | 0.10 mm 0.06 mm | Pass | {9}------------------------------------------------ {10}------------------------------------------------ | Test Method | Standard | Purpose of Testing | Acceptance Criteria | Results | Status | |----------------|---------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | Watertight | ASTM D5151 (Standard Test Method for Detection of Holesin Medical Gloves) | To detect holes that leak water and thereby compromise the usefulness of the glove. | Sample size: 315 pcs Inspection level: G1 AQL: 1.5, Acceptance No. 10 | The batch size for this sampling is 150,001 to 500,000. Hence, according to the single sampling plan GI, the sample to be drawn is under code M equivalent to 315 pieces with accept 10 and reject 11 to be accepted under AQL 1.5. For Size XS, during the test, 1piece was found with leaks. Hence it falls within the acceptance criteria. For Size S, during the test, 3piece was found with leaks. Hence it falls within the acceptance criteria. For Size M. during the test, 2piece was found with leaks. Hence it falls within the acceptance criteria. For Size L, during the test, 3piece was found with leaks. Hence it falls within the acceptance criteria. For Size XL, during the test, 1piece was found with leaks. Hence it falls within the acceptance criteria. | Pass | {11}------------------------------------------------ | Test Method | Standard | Purpose of Testing | Acceptance Criteria | Results | | Status | |--------------------|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|------------------------------------------------------|---------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|--------| | Residual Powder | ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves) | To determine the amount of residual and non-powder solids found on gloves | Less than 2 mg per glove Requirement : <2mg/glove | Sample size Result XS Result S Result M Result L Result XL | : 5 pcs :0.26mg/glove :0.32mg/glove :0.28mg/glove :0.34mg/glove :0.38mg/glove | Pass | {12}------------------------------------------------ #### 8.0 Non-clinical performance testing methods full titles: - ASTM D412 Test Methods for Vulcanized Rubber and Thermoplastic Elastomers— O Tension - ASTM D573 Test Method for Rubber—Deterioration in an Air Oven x ASTM D3578 o Specification for Rubber Examination Gloves - ASTM D6319 Standard Specification for Nitrile Examination Gloves for Medical o Application - ASTM D5151 Test Method for Detection of Holes in Medical Gloves o - ASTM D6124 Test Method for Residual Powder on Medical Gloves O - ISO 2859 Sampling Procedures and Tables for Inspection by Attributes Test results show O that under the conditions of the testing, there is no difference inphysical attributes between the proposed device and the predicate device. - ISO 10993 Part 10: Tests for Irritation and Sensitization. Both Skin Irritation and Dermal O Magnuson/Kligman Sensitization performed. - o ISO 10993 - Part 11: Tests for assessment of Systemic Toxicity #### 9.0 Summary of Clinical Testing No clinical testing is included in this submission #### 10.0 Conclusion The conclusion drawn from the non-clinical tests demonstrates that the subject "Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile" is as safe, as effective, and performs as well as, or better than the legally marketed predicate device predicate K190942.

Black Nitrile Powder Free Patient Examination Glove, Non Sterile

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Black Nitrile Powder Free Patient Examination Glove, Non Sterile

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Welcome

Check your email

Welcome!