Who is the manufacturer of Stronghold Group Nitrile Examination Glove, Powder Free?

Stronghold Group, LLC filed the 510(k) submission for Stronghold Group Nitrile Examination Glove, Powder Free (K213859).

What is the FDA product code for Stronghold Group Nitrile Examination Glove, Powder Free?

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 Stronghold Group Nitrile Examination Glove, Powder Free?

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

What are the predicate devices for Stronghold Group Nitrile Examination Glove, Powder Free?

Blue Nitrile Examination Gloves Powder Free (K203191).

Who can help prepare an FDA 510(k) submission like Stronghold Group Nitrile Examination Glove, Powder Free?

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.

Stronghold Group Nitrile Examination Glove, Powder Free

K213859 · Stronghold Group, LLC · LZA · Jan 13, 2022 · General Hospital

Device Facts

Record ID	K213859
Device Name	Stronghold Group Nitrile Examination Glove, Powder Free
Applicant	Stronghold Group, LLC
Product Code	LZA · General Hospital
Decision Date	Jan 13, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6250
Device Class	Class 1
Attributes	3rd-Party Reviewed

Intended Use

Stronghold Group Nitrile Examination Gloves, Powder Free is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.

Device Story

Disposable nitrile examination glove; worn on examiner's hands/fingers; prevents cross-contamination between patient and examiner. Used in clinical settings by healthcare professionals. Non-sterile; powder-free; blue color; finger-textured. Provides physical barrier protection. No electronic or software components.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM D6319-19 physical dimensions, tensile strength, elongation, and hole detection (AQL 2.5). Biocompatibility testing performed per ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), ISO 10993-11 (acute systemic toxicity), and ISO 10993-23 (skin irritation).

Technological Characteristics

Nitrile compound; non-sterile; powder-free; finger-textured; blue. Dimensions and physical properties comply with ASTM D6319-19. Biocompatibility per ISO 10993 series. No energy source, connectivity, or software.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or fingers 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

Blue Nitrile Examination Gloves Powder Free (K203191)

Related Devices

K211075 — Disposable Medical Nitrile Examination Gloves (Non-Sterile) · Jiangsu Cherish Medical Technology Co., Ltd. · Aug 5, 2021
K221192 — Disposable Nitrile Powder-Free Examination Gloves · Shandong Maida Medical Technology Co., Ltd. · Jun 22, 2022
K123488 — LINSHI NITRILE DISPOSABLE EXAM GLOVES, POWDER-FREE · Puyang Linshi Health Co., Ltd. · Feb 8, 2013
K040791 — POLYMER COAT, POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) · Pt. Smartglove Indonesia · Jun 3, 2004
K162491 — Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) · Hartalega Sdn Bhd · Feb 8, 2017

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 13, 2022 Stronghold Group LLC % Prithul Bom Mosr Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114 Re: K213859 Trade/Device Name: Stronghold Group Nitrile Examination Glove, Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA Dated: December 8, 2021 Received: December 10, 2021 Dear Prithul Bom: 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. 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K213859 Device Name Stronghold Group Nitrile Examination Gloves, Powder Free Indications for Use (Describe) Stronghold Group Nitrile Examination Gloves, Powder Free is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers 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}------------------------------------------------ # 510(K) Summary #### STRONGHOLD GROUP NITRILE EXAMINATION GLOVES, POWDER FREE Preparation Date: July 22, 2021 ### 1. SUBMITTER Company Name: Stronghold Group Company Address: 3409-B Ainslie Street, Philadelphia, PA 19129 Contact Person: David Henderson Telephone Number: +1.215.350.8855 Email: Dave@strongholdcare.com ### 2. NAME OF THE DEVICE Trade Name / Proprietary Name: Stronghold Group Nitrile Examination Gloves, Powder Free Device Name: Stronghold Group Nitrile Examination Gloves, Powder Free Device Classification Name: Patient Examination Gloves Device Class: Class I Device Classification Number: 21 CFR 880.6250 Product Code: LZA ## 3. IDENTIFICATION OF THE LEGALLY MARKETED DEVICE Predicate Device: K203191 Device Name: Blue Nitrile Examination Gloves Powder Free Device Classification Name: Patient Examination Gloves Device Classification Number: 21 CFR 880.6250 Device Class: Class I Product Code: LZA Review Panel: General Hospital ### 4. DEVICE DESCRIPTION The subject device in this 510(k) Notification is Stronghold Group Nitrile Examination Glove, Powder Free. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250. Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application. {4}------------------------------------------------ # 5. INTENDED USE OF THE DEVICE Stronghold Group Nitrile Examination Gloves, Powder Free is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. ## 6. TECHNOLOGICAL CHARACTERISTIC COMPARISON FOR THE PROPOSED AND PREDICATE DEVICES | | DEVICE PERFORMANCE | | | |--------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | CHARACTERISTICS | PREDICATE | SUBJECT | Remarks | | 510(k) Number | K203191 | TBD | | | Device Name | Nitrile Examination Gloves, Powder Free | Nitrile Examination Gloves, Powder Free | Same | | Product Code | LZA | LZA | Same | | Intended Use | LYDUS Nitrile Examination Gloves, Powder Free is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. | Stronghold Group Nitrile Examination Gloves, Powder Free is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. | Same | | Materials of Use (ASTM D6910/D6910M-19) | Nitrile compound | Nitrile compound | Same | | Color | Blue | Blue | Same | | Texture | Finger Textured | Finger Textured | Same | | Size (ASTM D6319-19) | Small, Medium, Large, Extra Large | Small, Medium, Large, Extra Large | Same | | Sterilization | Non-sterile | Non-sterile | Same | | Usage | Single usage | Single usage | Same | | Dimensions (ASTM D6319-19) | Length Min. 230 min Width Min 95+/-10 mm (for medium size) | Length Min. 230 min Width Min 95+/-10 mm (for medium size) | Same | | Physical Properties (ASTM D6319-19) | Before Aging Tensile Strength Min 14 Mpa Ultimate Elongation Min 500% After Aging Tensile Strength Min 14 Mpa Ultimate Elongation | Before Aging Tensile Strength Min 14 Mpa Ultimate Elongation Min 500% After Aging Tensile Strength Min 14 Mpa Ultimate Elongation | Same | | | Min 400% | | | | Thickness (ASTM D6319-19) | Palm min 0.05 mm Finger min 0.05 mm | Palm min 0.05 mm Finger min 0.05 mm | Same | | Powder Free (ASTM D6319-19) | ≤2 mg/glove | ≤2 mg/glove | Same | | Freedom from Holes (Water Tight -1000 ml) - ASTM D6319-19 (Cross Reference D5151) | Passed | Passed | Same | | Biocompatibility - SKIN SENSITIZATION - ISO 10993-10: 2010 (E) | Under the conditions of study not an irritant | Under the conditions of study not an irritant | Same | | Biocompatibility - SKIN IRRITATION - ISO 10993-10: 2010 (E) | Under the conditions of the study not a sensitizer | Under the conditions of the study not a sensitizer | Same | | Biocompatibility - IN VITRO CYTOTOXICITY - ISO 10993-5: 2009(E) | Exhibit cytotoxic reactivity at 100% extract concentration (Grade 4 with neat extract). Non-cytotoxic reactivity at 50%, 25%, 12.5% and 6.25% extract concentration. | Non-cytotoxic reactivity at all extract concentrations. | Similar | | Biocompatibility - ACUTE SYSTEMIC TOXICITY - ISO 10993-11: 2017(E) | No systemic toxicity under the experimental conditions employed | No systemic toxicity under the experimental conditions employed | Same | | Biocompatibility – Skin Irritation Test - ISO 10993-23 : 2021(E) | N/A | Report results show as non-irritant | Similar | | Manufacturer(s) | Nathan Trading Co., Ltd., Thailand | Stronghold Group | | {5}------------------------------------------------ There are no significant differences between the two products and are icentical in terms of intended use, materials, design, manufacturing methods. Both devices meet the AST D6319-19. {6}------------------------------------------------ # 8. NON-CLINICAL TESTING SUMMARY PERFORMANCE DATA | Test Method | Purpose | Acceptance Criteria | Result | |-----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------| | ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Dimensions Test | To determine the width, length, and thickness of the gloves | Width: 91 mm (Mean) (for medium size) Length: 241 mm (Mean)(for medium size) Thickness: Finger – 0.13 mm (Mean) Palm – 0.09 mm (Mean) | Passed | | ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Requirements Test | To determine the tensile strength and ultimate elongation before and after acceleration aging | Before Acceleration Aging: Tensile Strength (MPa): 34 (Mean) Ultimate Elongation (%): 601 (Mean) After Acceleration Aging: Tensile Strength (MPa): 34 (Mean) Ultimate Elongation (%): 571 (Mean) | Passed | | ASTM D6319-19 (ASTM D5151-11) Standard Test Method for Detection of Holes in Medical Gloves | To determine the holes in the gloves | AQL 2.5 | Passed | | ASMT D6319-19 (ASTM D6124-11) Standard Test Method for Residual Powder on Medical Gloves | To determine the residual powder in the gloves | $\leq$ 2.0 mg/glove | 0.12 mg/glove | | Test Method | Purpose | Acceptance Criteria | Result | | ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin irritation and skin sensitization | To determine the potential of the material under test to produce skin irritation in rabbits | Under the condition of study not an irritant | Under the condition of study not an irritant | | ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin irritation and skin sensitization | To determine the skin sensitization potential of the material both in terms of induction and elicitation in guinea pigs. | Under the conditions of the study not a sensitizer. | Under the conditions of the study not a sensitizer. | | ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | To evaluate the in vitro cytotoxic potential of the test item (both inner and outer surface) Extracts in L-929 mouse fibroblasts cells using elution method | Under the conditions of study non cytotoxic | Non-cytotoxic reactivity at 100%, 50%, 25%, 12.5% and 6.25% extract concentration. | | ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for acute systemic toxicity | The test item was evaluated for acute systemic toxicity in Albino Mice | Under the conditions of the study no systemic toxicity | Under the conditions of the study no systemic toxicity | | ISO 10993-23 : 2021 Biological evaluation of medical devices Part 23: Tests for skin irritation | The test item was evaluated for skin irritation using in vitro reconstructed human epidermis model EpiDerm Skin Irritation Test | Under the conditions of the study, no skin irritation | Under the conditions of the study, no skin irritation | {7}------------------------------------------------ # 9. BIO-COMPATIBILITY DATA # 10. CLINICAL TESTING SUMMARY Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(k) process. # 11. CONCLUSION The conclusions drawn from the non-clinical test demonstrate that the subject device in 510(k) submission, the Stronghold Group Nitrile Examination Gloves, Powder Free is as safe, as effective, and performs as well as or better than the legally marketed predicate device K203191.

Stronghold Group Nitrile Examination Glove, Powder Free

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

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Stronghold Group Nitrile Examination Glove, Powder Free

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

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Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

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