(166 days)
Not Found
No
The device description and performance studies focus on the physical and biocompatibility properties of examination gloves, with no mention of AI or ML.
No
The device, Tegamen Nitrile Patient Examination gloves, is intended to prevent contamination between patient and examiner, not to treat or cure a disease or condition.
No
Explanation: The device, Tegamen Nitrile Patient Examination gloves, is described as a disposable device intended for medical purposes to prevent contamination between patient and examiner. There is no mention of it being used to diagnose any condition or disease.
No
The device is a physical examination glove made of nitrile, clearly described as a hardware device intended to be worn on the hand.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gloves are "worn on the examiners' hand or finger to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description focuses on the physical properties and materials of the glove, not on any components or processes used for analyzing samples or diagnosing conditions.
- Lack of IVD Indicators: The provided text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes or markers
- Providing diagnostic information
- Using reagents or assays
The device is a Class I medical device intended for barrier protection during patient examination.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LZA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Non-Clinical Testing
Sample Size: Not explicitly stated for each test, but results are given in terms of mean values or total defects.
Key Results:
- ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Dimensions Test: Pass. Length (mm) Mean Value – 239.45. Width (mm) Mean Value – 84.7 (small), 95.9 (medium), 105.8 (large), 115.5 (extra large). Thickness at finger (mm) Mean Value – .13. Thickness at Palm (mm) Mean Value – 0.065.
- ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Requirements Test: Pass. MPa (Mean Value) - 23.24 before aging; MPa (Mean Value) – 22.62 after aging. Ultimate Elongation (Mean Value) 851.9 before aging; Ultimate Elongation (Mean Value) 808.7 after aging.
- ASTM D6319-19 (ASTM D5151-11) Standard Test Method for Detection of Holes in Medical Gloves: Pass. Total Defects - 01 (Holes found 1).
- ASMT D6319-19 (ASTM D6124-11) Standard Test Method for Residual Powder on Medical Gloves: Pass. Powder Content (mg/glove) – 1.335.
- ISO 10993-10 Biological evaluation of medical devices – Part 10: Tests for skin irritation and skin sensitization (skin irritation): 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 (skin sensitization): Under the conditions of the study not a sensitizer.
- ISO 10993-5 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity: Based upon the results obtained in this study and in line with ISO 10993-5:2009, it is concluded that the given test item, Tegamen Nitrile Examination, supplied by Tegamen Safety Products Pvt Ltd., is considered as cytotoxic in undiluted extract, 1:2, 1:4, 1:8, and 1:16 dilutions. Non-cytotoxic to L-929 cells at 1:32 dilutions.
- ISO 10993-11:2017 Biological evaluation of medical devices– Part 11: Tests for acute systemic toxicity: Under the conditions of the study no acute systemic toxicity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Freedom from Holes (ASTM D6319-19): AQL2.5 Passed
- Powder Free (ASTM D6319-19):
§ 880.6250 Non-powdered patient examination glove.
(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
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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.
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 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,
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
2
Indications for Use
Submission Number (if known)
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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3
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 arora297consultancy@gmail.com
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 |
| PLOT No: 14-A, COCHIN SPECIAL ECONOMIC ZONE, | |
| KAKKANAD | |
| COCHIN, IN 682037 |
4
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
5
| 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 | ||
| 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. | The subject device is a patient examination | ||
| glove made of synthetic nitrile | |||
| latex compound. It is non-sterile, powderfree | |||
| and is Blue in color. The device is | |||
| ambidextrous and can be worn on either the | |||
| eft or right hand. The device meets ASTM | |||
| 06319-10: Standard specification for Nitrile | |||
| Examination Gloves for Medical Application. | |||
| 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 | ||
| a disposable device intended for medical | |||
| purposes that is worn on the examiners hand | |||
| or finger to prevent contamination between | |||
| patient and examiner. | The 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 | Same | ||
| Attribute | Tegamen Nitrile Examination Gloves | ||
| K223102 | Nitrile Patient Examination gloves, Powderfree, Blue Color | ||
| (K143477) | Comparison | ||
| Color | Blue | Blue | Same |
| Size | |||
| (ASTM D6319-19) | Small, Medium, Large, | ||
| Extra Large | Extra Small, Small, Medium, Large, Extra | ||
| Large | Similar | ||
| Freedom from Holes | |||
| (ASTM D6319-19) | Passed AQL2.5 | Passed AQL2.5 | Similar |
| Single Use | Yes | Yes | Same |
| Ambidextrous | Yes | Yes | 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 Min 400 | Before Aging Tensile Strength Min 14 Mpa | ||
| Ultimate Elongation Min 500 | |||
| After Aging | |||
| Tensile Strength Min 14 Mpa | |||
| Ultimate Elongation Min 400 | Similar | ||
| Powder Free | |||
| (ASTM D6319-19) | 230 mm (240-400mm) | ||
| Width 70±10 mm to 120±10 mm (sizes XS to XL) | |||
| Thickness > 0.05 mm | |||
| (palm & finger) | Pass | ||
| Length (mm) Mean | |||
| Value – | |||
| 239.45 | |||
| Width (mm) Mean | |||
| Value – | |||
| 84.7 (small), 95.9 | |||
| (medium), 105.8 | |||
| (large), 115.5 | |||
| (extra large) | |||
| Thickness at finger | |||
| (mm) | |||
| Mean Value – .13 | |||
| Thickness at Palm | |||
| (mm) | |||
| Mean Value – | |||
| 0.065 | |||
| 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 14 Mpa min before aging | |||
| Ultimate Elongation 500 % min before aging |
After Acceleration Aging:
Tensile Strength 14 Mpa min after aging Ultimate
Elongation 400 % min after aging | Pass
MPa (Mean Value) - 23.24
before aging
MPa (Mean Value) –
22.62
after aging
Ultimate Elongation
(Mean
Value) 851.9 before aging
Ultimate Elongation
(Mean
Value) 808.7 after aging |
| 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 | Pass
Total Defects - 01
(Holes
found 1) |
| ASMT D6319-19
(ASTM D6124-11)
Standard Test Method
for Residual Powder on
Medical Gloves | To determine the
residual powder
in the gloves | ≤ 2.0 mg/glove | Pass
Powder Content
(mg/glove)
– 1.335 |
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BIO-COMPATIBILITY DATA
| 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
cytotoxic | Based upon the results
obtained in this study and in
line with ISO 10993-5:2009,
it is concluded that the given
test item, Tegamen Nitrile
Examination, supplied by
Tegamen Safety Products
Pvt Ltd., is considered as
cytotoxic in undiluted
extract, 1:2, 1:4, 1:8, and
1:16 dilutions. Non-
cytotoxic to L-929 cells at
1:32 dilutions |
| 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 Swiss
Albino Mice | Under the
conditions
of the
study no
acute
systemic
toxicity | Under the conditions of the
study no acute systemic
toxicity |
10
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.