Tegamen Nitrile Examination Gloves

K223102 · M/S Tegamen Safety Products Private Limited · LZA · Mar 15, 2023 · General Hospital

Device Facts

• Record ID: K223102
• Device Name: Tegamen Nitrile Examination Gloves
• Applicant: M/S Tegamen Safety Products Private Limited
• Product Code: LZA · General Hospital
• Decision Date: Mar 15, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Tegamen Nitrile Patient Examination gloves, is a disposable device intended for medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner.

Device Story

Tegamen Nitrile Examination Gloves are disposable, non-sterile, blue nitrile compound gloves. Used by healthcare professionals during patient examinations to provide a barrier against contamination. Device is ambidextrous and available in sizes Small through Extra Large. Performance is verified against ASTM D6319-19 standards for physical dimensions, tensile strength, elongation, and freedom from holes. Biocompatibility testing confirms the material is not a skin irritant or sensitizer. The device functions as a physical barrier; no electronic or software components are involved.

Clinical Evidence

Bench testing only. No clinical data was required or provided. Performance was validated through physical testing (ASTM D6319-19) for dimensions, tensile strength, elongation, freedom from holes (AQL 2.5), and residual powder content. Biocompatibility was assessed per ISO 10993 standards, including skin irritation, skin sensitization, acute systemic toxicity, and in vitro cytotoxicity.

Technological Characteristics

Material: Nitrile compound. Form factor: Ambidextrous, blue, powder-free, non-sterile glove. Standards: ASTM D6319-19 (physical properties, dimensions, freedom from holes), ASTM D5151-11, ASTM D6124-11. Biocompatibility: ISO 10993-5, ISO 10993-10, ISO 10993-11. No energy source, connectivity, or software.

Indications for Use

Indicated for use as a disposable, non-sterile, patient examination 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

• Nitrile Patient Examination gloves, Powderfree, Blue Color (K143477)

Submission Summary (Full Text)

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March 15, 2023

M/S Tegamen Safety Products Private Limited % Avinash Arora Consultant Arora 297 Consultancy 229 Deer Ridge Dr Kitchener, ON N2P2k5 Canada

Re: K223102

Trade/Device Name: Tegamen Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA Dated: February 10, 2023 Received: February 10, 2023

Dear Avinash Arora:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely,

# Bifeng Qian -S

Bifeng Qian, 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 Quality Center for Devices and Radiological Health

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# Indications for Use

Submission Number (if known)

K223102

Device Name

Tegamen Nitrile Examination Gloves

Indications for Use (Describe)

Tegamen Nitrile Patient Examination gloves, is a disposable device intended for medical purposes that is worn on the examiners' 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)

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## 510(k) Summary K223102

# As required by 21CFR§807.92

#### 1. 510(k) Submitter

Avinash K Arora Arora 297 Consultancy 229 Deer Ridge Dr Kitchener, ON Canada - N2P2k5 +1.5194985957 [e-mail]

### 2. Manufacturer

Tegamen Safety products Ltd Sp7-52, Ricco Industrial Area Ghiloth Alwar, Rajasthan, 301705 India

## 3. Preparation Date: Mar 8, 2023

#### 4. Device Identification

| Trade/Proprietary Name: | Tegamen Nitrile Examination Gloves |
|-------------------------|------------------------------------------|
| Common/Usual Name: | Nitrile Examination Gloves |
| Classification Name: | Patient Examination Gloves |
| Regulation Number: | 21 CFR 880.6250 |
| Product Code: | LZA |
| Device Class: | Class I |
| Classification Panel: | General Plastic Surgery/General Hospital |

# 5. Legally Marketed Predicate Device(s)

| Device name: | Nitrile Patient Examination gloves, Powderfree, Blue Color |
|----------------|------------------------------------------------------------------------------------------------------------|
| 510(k) number: | K143477 |
| Manufacturer: | PRIMUS GLOVES PVT LIMITED<br>PLOT No: 14-A, COCHIN SPECIAL ECONOMIC ZONE,<br>KAKKANAD<br>COCHIN, IN 682037 |

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## 6. Indications for Use

Tegamen Nitrile Patient Examination Gloves, is a disposable device intended for medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner.

## 7. Device Description

The subject device in this 510(k) Notification is Tegamen Nitrile Examination Gloves, 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.

#### 8. Substantial Equivalence Discussion

The following table compares the subject Tegamen Nitrile Examination Gloves to the selected predicate device. The comparisons include the following attributes which forms the basis for determining substantial equivalence:

- . Indications for use,
- . Technological characteristics, and
- . Device performance

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| | | Table 1: Comparison of Characteristics |
|--|--|-----------------------------------------|
|--|--|-----------------------------------------|

| Attribute | Tegamen Nitrile Examination Gloves | Nitrile Patient Examination gloves, Powderfree, Blue | Same / Similar / Different |
|----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| | K223102 | (K143477) | |
| Manufacturer | Tegamen Safety Products Ltd | Primus Gloves Private Ltd | Different |
| Product Code | LZA | LZA | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Device Description | The subject device in this 510(k) Notification is<br>Tegamen Nitrile Examination Gloves, Powder<br>Free. The subject device is a patient<br>examination glove made from nitrile compound,<br>blue color, powder free and non-sterile (Per 21<br>CFR 880.6250, Class I). The device meets the<br>specifications in ASTM D6319-19 Standard<br>Specification for Nitrile Examination Gloves<br>for Medical Application. | The subject device is a patient examination<br>glove made of synthetic nitrile<br>latex compound. It is non-sterile, powderfree<br>and is Blue in color. The device is<br>ambidextrous and can be worn on either the<br>eft or right hand. The device meets ASTM<br>06319-10: Standard specification for Nitrile<br>Examination Gloves for Medical Application.<br>The device is for over-the counter single use. | Similar |
| Materials of Use | Nitrile compound | Nitrile compound | Same |
| Sterile | No | No | Same |
| Indications for Use | Tegamen Nitrile Patient Examination gloves is<br>a disposable device intended for medical<br>purposes that is worn on the examiners hand<br>or finger to prevent contamination between<br>patient and examiner. | The examination gloves is a disposable device<br>intended for medical purposes that is worn on<br>the examiners hand or finger to prevent<br>contamination between patient and examiner | Same |
| Attribute | Tegamen Nitrile Examination Gloves<br>K223102 | Nitrile Patient Examination gloves, Powderfree, Blue Color<br>(K143477) | Comparison |
| Color | Blue | Blue | Same |
| Size<br>(ASTM D6319-19) | Small, Medium, Large,<br>Extra Large | Extra Small, Small, Medium, Large, Extra<br>Large | Similar |
| Freedom from Holes<br>(ASTM D6319-19) | Passed AQL2.5 | Passed AQL2.5 | Similar |
| Single Use | Yes | Yes | Same |
| Ambidextrous | Yes | Yes | Same |
| Physical<br>Properties<br>(ASTM<br>D6319-19) | Before Aging Tensile Strength Min 14 Mpa<br>Ultimate Elongation Min 500<br>After Aging<br>Tensile Strength Min 14 Mpa<br>Ultimate Elongation Min 400 | Before Aging Tensile Strength Min 14 Mpa<br>Ultimate Elongation Min 500<br>After Aging<br>Tensile Strength Min 14 Mpa<br>Ultimate Elongation Min 400 | Similar |
| Powder Free<br>(ASTM D6319-19) | <2 mg/glove | <2 mg/glove | Similar |
| Dimensions<br>(ASTM D6319-19) | Overall Length 239 min | Overall Length 240 min | Similar |
| Thickness<br>(ASTM D6319-19) | Palm min 0.05 mm<br>Finger min 0.05 mm | Palm min 0.05 mm<br>Finger min 0.05 mm | Similar |
| Biocompatibility -<br>Cytotoxicity | Under the<br>conditions of<br>study<br>cytotoxic | NA | Different<br>Not conducted on<br>predicate device |
| Biocompatibility -<br>Acute systemic<br>toxicity | Under the conditions of the<br>study no acute systemic<br>toxicity | NA | Different<br>Not conducted on<br>predicate device. |
| Biocompatibility -<br>SKIN<br>SENSITIZATION -<br>ISO 10993-10:<br>2010 (E) | Under the<br>conditions of<br>study not a sensitizer | Under the<br>conditions of<br>study not a sensitizer | Similar |
| Biocompatibility -<br>SKIN<br>IRRITATION -<br>ISO<br>10993-10: 2010 (E) | Under the<br>conditions of<br>study not an irritant | Under the<br>conditions of<br>study not an irritant | Similar |

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# 9 . Non-Clinical Testing Summary PERFORMANCE DATA

| Test Method | Purpose | Acceptance Criteria | Result |
|-----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASMT D6319-19<br>Standard Specification<br>for Nitrile Examination<br>Gloves for Medical<br>Application - Physical<br>Dimensions Test | To determine the<br>width, length, and<br>thickness of the<br>gloves | Length > 230 mm (240-400mm)<br>Width 70±10 mm to 120±10 mm (sizes XS to XL)<br>Thickness > 0.05 mm<br>(palm & finger) | Pass<br>Length (mm) Mean<br>Value –<br>239.45<br>Width (mm) Mean<br>Value –<br>84.7 (small), 95.9<br>(medium), 105.8<br>(large), 115.5<br>(extra large)<br>Thickness at finger<br>(mm)<br>Mean Value – .13<br>Thickness at Palm<br>(mm)<br>Mean Value –<br>0.065 |
| ASMT D6319-19<br>Standard Specification<br>for Nitrile Examination<br>Gloves for Medical<br>Application - Physical<br>Requirements Test | To determine the<br>tensile strength<br>and ultimate<br>elongation before<br>and after<br>acceleration aging | Before Acceleration Aging:<br>Tensile Strength 14 Mpa min before aging<br>Ultimate Elongation 500 % min before aging<br><br>After Acceleration Aging:<br>Tensile Strength 14 Mpa min after aging Ultimate<br>Elongation 400 % min after aging | Pass<br>MPa (Mean Value) - 23.24<br>before aging<br>MPa (Mean Value) –<br>22.62<br>after aging<br>Ultimate Elongation<br>(Mean<br>Value) 851.9 before aging<br>Ultimate Elongation<br>(Mean<br>Value) 808.7 after aging |
| ASTM D6319-19<br>(ASTM D5151-11)<br>Standard Test Method<br>for Detection of Holes in<br>Medical Gloves | To determine the<br>holes in the<br>gloves | AQL 2.5 | Pass<br>Total Defects - 01<br>(Holes<br>found 1) |
| ASMT D6319-19<br>(ASTM D6124-11)<br>Standard Test Method<br>for Residual Powder on<br>Medical Gloves | To determine the<br>residual powder<br>in the gloves | ≤ 2.0 mg/glove | Pass<br>Powder Content<br>(mg/glove)<br>– 1.335 |

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# BIO-COMPATIBILITY DATA

| Test<br>Method | Purpose | Acceptance<br>Criteria | Result |
|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 10993-10 Biological<br>evaluation of medical devices –<br>Part 10: Tests for skin irritation<br>and skin sensitization | To determine the potential of the<br>material under test to produce<br>skin irritation in rabbits | Under the<br>condition<br>of study<br>not an<br>irritant | Under the condition of<br>study not an irritant |
| ISO 10993-10<br>Biological<br>evaluation of medical devices –<br>Part 10: Tests for skin irritation<br>and skin sensitization | To determine the skin<br>sensitization potential of<br>the material both in terms<br>of induction and elicitation<br>in guinea pigs. | Under the<br>conditions<br>of the<br>study not a<br>sensitizer. | Under the conditions of the<br>study not a sensitizer. |
| ISO 10993-5 Biological<br>evaluation of medical devices –<br>Part 5: Tests for in vitro<br>cytotoxicity | To evaluate the in vitro cytotoxic<br>potential of the test item (both<br>inner and outer surface) Extracts<br>in L-929 mouse fibroblasts cells<br>using elution method | Under the<br>conditions<br>of study<br>cytotoxic | Based upon the results<br>obtained in this study and in<br>line with ISO 10993-5:2009,<br>it is concluded that the given<br>test item, Tegamen Nitrile<br>Examination, supplied by<br>Tegamen Safety Products<br>Pvt Ltd., is considered as<br>cytotoxic in undiluted<br>extract, 1:2, 1:4, 1:8, and<br>1:16 dilutions. Non-<br>cytotoxic to L-929 cells at<br>1:32 dilutions |
| ISO 10993-11:2017 Biological<br>evaluation of medical devices–<br>Part 11: Tests for acute systemic<br>toxicity | The test item was evaluated for<br>acute systemic toxicity in Swiss<br>Albino Mice | Under the<br>conditions<br>of the<br>study no<br>acute<br>systemic<br>toxicity | Under the conditions of the<br>study no acute systemic<br>toxicity |

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# 10. Clinical Testing summary

Not applicable - Clinical data is not needed for the subject gloves.

# 11. Conclusion

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