(45 days)
Not Found
Not Found
No
The document describes standard nitrile examination gloves and provides performance data related to physical properties and quality control, with no mention of AI or ML.
No.
The intended use of the device is to prevent contamination between patient and examiner, which aligns with diagnostic or preventative purposes, not therapeutic ones.
No
Explanation: The device is described as a "Nitrile examination glove," which is a protective barrier worn to prevent contamination. Its intended use and characteristics listed (length, width, thickness, physical properties) relate to its physical integrity and protective function, not to the diagnosis of diseases or conditions.
No
The device is a physical glove made of Nitrile Latex, not a software program. The description and performance data relate to physical properties and testing of the glove material.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to prevent contamination between patient and examiner" by being worn on the hand or finger. This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: It's described as a "Class I Nitrile Examination Glove." Examination gloves are generally considered medical devices, but not IVDs.
- Lack of Diagnostic Function: There is no mention of the device being used to test specimens (like blood, urine, tissue, etc.) or to provide information about a patient's health status or condition.
- Performance Data: The performance data focuses on physical properties of the glove (length, width, thickness, tensile strength, elongation, freedom from holes, powder content, protein content, moisture content, biocompatibility). These are relevant to the glove's barrier function and safety, not to a diagnostic test.
IVD devices are specifically designed to perform tests on specimens from the human body to provide information for diagnosis, monitoring, or screening. This glove does not fit that description.
N/A
Intended Use / Indications for Use
Nitrile examination glove (Powder free) is a Powder free devices made of Nitrile Latex intent for medical purpose 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
Class I Nitrile Examination Gloves ( Powder free) 80LZA that meets all the requirements of ASTM D3578- 95.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
The performance test data of the Nitrile Examination Glove powder free manufactured by SRI ANUSHAM RUBBER INDUSTRIES PVT.LTD. is given below.
The Nitrile Examination gloves Powder free manufactured by SRI. ANUSHAM RUBBER INDUSTRIES PVT.LTD.
- Meet or exceed the ASTM D3578 -
- Meet FDA Pin hole Requirement. .
- Meet labelling claim as shown by the data in 6 *
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The document contains tables with the following key metrics for Nitrile Examination gloves (Powder free):
- Characteristic (measured values for EX-S, S, M, L sizes): Length, Width, Thickness
- Physical Properties (BEFORE AGEING / AFTER AGEING): Tensile Strength, Elongation at break %
- Performance Requirement (AQL followed by SARI and AQL Value as per ASTM D3578): Freedom from Holes, Dimension (Width, Length, Thickness), Physical Property (Tensile Strength, Elongation at Break)
- Powder Content: SARI VALUE (Nil Powder), ASTM REQUIREMENT (2 mg/glove max)
- Protein Content: CADI VALUE (1), ·REQUIREMENT (Value not fixed)
- Moisture Content: SARI VALIE (0.8% max), REOLITREMENT (valle tixed)
- Biocompatability: SARI GLOVE (Biologically Compatible), FDA REQUIREMENT (Biologically Compatible)
- Performance Data (repeated values from section 7.0 for the subject device): Length, Width, Thickness
- Physical Properties (repeated values from section 7.0 for the subject device): Tensile Strength, Elongation at break %
- Inspection Level of AQL (repeated values from section 7.0 for the subject device): Freedom from Holes, Dimension, Physical Property
- POWDER CONTENT : 1 +/- 1 mg per glove
- PROTEIN CONTENT: 30 +/- 10 ppm
- MOISTURE CONTENT: .0.8% max
- BIOCOMPATABILITY: Biologically Compatible.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
PAGE NO- 57
510K SUMMARY as required by: 807.92( c ) 1.0.
:
2.0 APPLICANT
NAME
ADDRESS
M/s. SRI.ANUSHAM RUBBER INDUSTRIES PVT.LTD.
PIONEER MANIKANDAN BUILDINGS. VADASERY,NAGERCOIL, TAMIL NADU, INDID - 629001.
91-4652- 33091 / 32506 .
91-4652-32871
PH.NO.
FAX NO
CONTACT PERSON .. MR. N.PARAMASIVAN MANAGING DIRECTOR.
..
:
-
DEVICE TRADE NAME : NIL : Nitrile Examination Glove (Powder frec) COMMON NAME
-
Legally marketed device to which the company claiming equivalence: Class I Nitrile Examination Gloves ( Powder free) 80LZA that meets all the requirements ( ASTM D3578 - 95.
-
DESCRIPTION OF THE DEVICE :
Class I Nitrile Examination Gloves ( Powder free) 80LZA that meets all the requirements of ASTM D3578- 95.
- Intended use of the Device:
Nitrile examination glove (Powder free) is a Powder free devices made of Nitrile Latex intent for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
Image /page/0/Picture/16 description: The image shows a circular stamp with the words "ANUSHAM RUBBER INDUSTR" and "NAGERCOIL" written on it. The text is arranged in a circular pattern around the center of the stamp. The stamp appears to be used, as the ink is not evenly distributed and there are some smudges.
1
PAGE NO-58
7.0 TECHNOLOGICAL CHARACTERSTICS OF THE DEVICE COMAPARED TO PREDICATE DEVICE.
| Measured Parameters of Nitrile
Examination gloves (Powder free)
manufactured by Sri.Anusham Rubber
industries Pvt. Ltd., | | | ASTM D3578
Requirement for
Nitrile Examination
glove (Powder free) |
|-----------------------------------------------------------------------------------------------------------------------------------|------|------------|-----------------------------------------------------------------------------|
| Characteristic | SIZE | Value | |
| 1. Length | EX-S | 235-240 mm | 220 mm minimum |
| | S | 235-240 mm | 220 mm minimum |
| | M | 235-240 mm | 230 mm minimum |
| | L | 235-240 mm | 230mm minimum |
| 2. Width | EX S | 70MM | 70 +/- 6 mm |
| | S | 82 mm | 80 +/- 6 mm |
| | M | 93 mm | 95 +/- 6 mm |
| | L | 107 mm | 111+/- 6mm |
| 3. Thickness | EX S | 0.10mm | 0.08 mm minimum |
| | S | 0.10mm | 0.08 mm minimum |
| | M | 0.10mm | 0.08 mm minimum |
| | L | 0.10mm | 0.08 mm minimum |
PHYSICAL PROPERTIES
| BEFORE AGEING | AFTER AGEING | |||
|---|---|---|---|---|
| CHARACTERISTICS | SARI VALUE * | ASTD 3578 | ||
| REQUIREMENT | SARI VALUE | ASTD 3578 | ||
| Requirement | ||||
| Tensile Strength | 18 - 20 mpa | 14 mpa min | 16 - 18 mpa | 14 mpa min |
| Elongation at break % | 750 - 800% | 700% min | 650-700% | 500% min |
SARI - SRI.ANUSHAM RUBBER INDUSTRIES .
WARM RUBBER INDUSTRIES PVT. LTD.
NAGERCOIL
2
PAGE NO-59
PERFORMANCE REQUIREMENT
| Characteristics | Related defects | Level followed
By | | AQL
followed by
SARI | AQL Value as
per ASTM
D3578. |
|-----------------------|-------------------------------------------------|----------------------|-------------------------|----------------------------|------------------------------------|
| | | SARI | As per
ASTM
D3578 | | |
| Freedom from
Holes | Holes | S4 | S4 | 1.5 | 4 |
| Dimension | Width, Length
Thickness. | S2 | S2 | 4 | 4 |
| Physical
Property | Tensile
Strength,
Elongation at
Break. | S2 | S2 | 4 | 4 |
POWDER CONTENT
| SARI VALUE | ASTM REQUIREMENT |
|---|---|
| Nil Powder | 2 mg/glove max |
PROTEIN CONTENT:
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | · REQUIREMENT |
|---|---|
| CADI VALUE | 1 |
| יי החם | |
| 10 pom 11 | Value not fixed |
MOISTURE CONTENT:
| SARI VALIE | REOLITREMENT |
|---|---|
| of Cattle. | |
| 0.8% . | |
| max | valle tixed |
| . | |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
BIOCOMPATABILITY:
| SARI GLOVE | FDA REQUIREMENT |
|---|---|
| Biologically Compatible | Biologically Compatible |
Image /page/2/Picture/11 description: The image shows a circular stamp with the text "PUSHAM RUBBER INDUSTR S PVT LTD" around the border. In the center of the stamp, the text "NAGERCOIL" is written in a slightly tilted manner. The stamp appears to be somewhat faded or worn, giving it a vintage or used look.
3
8.0 Performance Data:
The performance test data of the Nitrile Examination Glove powder free manufactured by SRI ANUSHAM RUBBER INDUSTRIES PVT.LTD. is given below.
| Characteristic
| s | SIZE | Value |
|---|---|---|
| 1. Length | EX-S | 235-240 mm |
| S | 235-240 mm | |
| M | 235-240 mm | |
| L | 235-240 mm | |
| 2. Width | EX S | 70MM |
| S | 82 mm | |
| M | 93 mm | |
| L | 107 mm | |
| 3. Thickness | EX S | 0.10mm |
| S | 0.10mm | |
| M | 0.10mm | |
| L | 0.10mm |
PHY SICAL PROPERTIES
| CHARACTERISTICS | Before Ageing | After Ageing |
|---|---|---|
| Tensile Strength | 18 - 20 mpa | 16 - 18 mpa |
| Elongation at break % | 750 - 800% | 650-700% |
INSPECTION LEVEL OF AQL:
| Characteristics | Related defects | Level | AQL |
|---|---|---|---|
| Freedom from | |||
| Holes | Holes | S4 | 1.5 |
| Dimension | Width , Length | ||
| Thickness. | S2 | 4 | |
| Physical | |||
| Property | Tensile | ||
| Strength, | |||
| Elongation at | |||
| Break. | S2 | 4 |
RUBBER INDUSTRY
4
POWDER CONTENT : 1 +/- 1 mg per glove
PROTEIN CONTENT: 30 +/- 10 ppm
MOISTURE CONTENT: .0.8% max
BIOCOMPATABILITY: Biologically Compatible.
NA 9. Clinical Data :
7. CONCLUSION OF PERFORMANCE TEST DATA:
The Nitrile Examination gloves Powder free manufactured by SRI. ANUSHAM RUBBER INDUSTRIES PVT.LTD.
- Meet or exceed the ASTM D3578 -
- Meet FDA Pin hole Requirement. .
- Meet labelling claim as shown by the data in 6 *
8. ANY OTHER INFORMATION:
Any other information required by FDA regarding product safety and effectiveness will be provided on request.
Image /page/4/Picture/13 description: The image is a circular stamp with text around the perimeter and in the center. The text around the perimeter reads "SRI ANUSHAM RUBBER INDUSTRIES PVT. LTD.". The text in the center reads "NAGERCOIL". There is a star symbol on the bottom left of the stamp.
5
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol of three stylized human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 1999
Mr. N. Paramasivan Managing Director SRI Anusham Rubber Industries Private, Limited Pioneer Manikandan Buildings Vadasery, Nagercoil-629001 Tamil Nadu, S. India
K993348 Re : Nitrile Examination Glove-Powder Free Trade Name: Requlatory Class: I Product Code: LZA September 28, 1999 Dated: Received: October 5, 1999
Dear Mr. Paramasivan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in
6
Page 2 - Mr. Paramasivan
the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
7
PAGE NO :3
3.0 INDICATIONS FOR USE:
| APPLICANT | : SRI.ANUSHAM RUBBER INDUSTRIES PVT.LTD. |
|---|---|
| 510(K) No. | : K 993348 |
| DEVICE NAME | : NITRILE EXAMINATION GLOVES POWDER FREE |
INDICATIONS FOR USE:
Nitrile Examination Gloves Powder free is a powder free disposable device made of Nitrile Latex intended for medical purpose, that is worn on the examiners hand or finger to prevent contamination between patient and Examiner.
Image /page/7/Picture/5 description: The image shows a circular stamp with the text "M. SHAM RUBBER INDUSTRIES PVT. LTD." around the outer edge. In the center of the stamp, the word "NAGERCOIL" is printed in a slightly curved manner. The stamp appears to be somewhat faded or worn, giving it a vintage or used look.
Evin S. Lin
(Division Sign-Off) ് അമേന of Dental, Infection Control, and Ceneral Hospital Dey 510(k) Number .