(73 days)
Not Found
Not Found
No
The device is a standard examination glove and the summary describes physical properties and performance testing related to material integrity, not computational capabilities.
No
The device, a Fowder Free Latex Examination Glove, is intended to prevent contamination and is not designed to treat or diagnose a disease or condition.
No
Explanation: The device is described as a "Powder Free Latex Examination Glove," which is intended to prevent contamination between a patient and an examiner. This is a barrier device for protection, not a device used to diagnose a medical condition.
No
The device description clearly states it is a physical product (gloves) and provides physical measurements and performance data related to the material and construction of the gloves. There is no mention of software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is "worn by the Examiner on his hands / fingers to prevent contamination between Patient and Examiner." This is a barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: It is described as a "Class 1- Patient Examination Gloves." Examination gloves are physical barriers, not diagnostic devices.
- Lack of Diagnostic Elements: The description and performance data focus on physical properties of the glove (length, width, thickness, tensile strength, elongation, freedom from holes, powder content, protein content, moisture content, biocompatibility). There is no mention of analyzing a sample from the patient or providing any diagnostic information.
- No Mention of IVD-Related Activities: There is no mention of analyzing blood, urine, tissue, or any other biological sample, which are typical activities for IVD devices.
In summary, this device is a medical glove intended for barrier protection, not for performing diagnostic tests.
N/A
Intended Use / Indications for Use
Fowder Free Latex Examination Glove is a device intended for medical use , worn by the Examiner on his hands / fingers to prevent contamination between Patient and Examiner.
Product codes
Lyy
Device Description
Class 1- Patient Examination Gloves(Powder Free) ROL YY that meets all the requrements ASTM D 3578-95.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands / fingers
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
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 Powder Free Examination Gloves manufactured by SRI ANUSHAM RUBBER INDUSTRIES PVT LIMITED is given here-under:
Measured Parameters of Latex Examination Gloves (Powder Free) manufactured by SRI ANUSHAM RUBBER INDUSTRIES PRIVATE LIMITED:
Length: Ex-S (240 - 245 mm), S (240 - 245 mm), M (240 - 245 mm), L (245 - 250 mm), Ex-L (245 - 250 mm)
Width: Ex-S (71mm), S (82mm), M (95mm), L (106mm), Ex-L (110mm)
Thickness: Ex-S (0.11mm), S (0.12mm), M (0.12mm), L (0.10mm), Ex-L (0.11mm)
PHYSICAL PROPERTIES:
Tensile Strength: Before Ageing (21-24 mpa), After Ageing (19-22 mpa)
Elongation at break %: Before Ageing (800-850%), After Ageing (700- 800%)
INSPECTION LEVEL OF AQL:
Freedom from holes: Holes (S4, AQL 1.5)
Dimensions: Length, Width & Thickness (S2, AQL 4)
Physical Properties: Tensile Strength, Elongation at Break before & after aging (S2, AQL 4)
POWDER CONTENT: 1 +/- 1 mg per glove
PROTEIN CONTENT: 80 +/- 20 ppm
MOISTURE CONTENT: 0.4% maximum
BIO-COMPATIBILITY: Biologically Compatible
CONCLUSION OF PERFURMANCE UF TEST DATA
The Powder Free Gloves manufactured by SRI ANUSHAM RUHBER INDUSTRIES PRIVATE LIMITED;
- Meet or excreed the ASTM DJ578-45 Specifications
- Meet FDA Pin Hole Requirements
- Meet Labelling Claim as shown in data under S.No.6
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
SRI ANUSHAM RUBBER INDUSTRIES TEL: 91 4952 PRIVATE LIMITED 100% EXPORT ORIENTED UNIT
ﮨﮯ ﮐﮧ ﺍﯾﺎ ﮐﺎ ﻟﯿﺎﮞ ﮐﮯ ﻟﯿﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﮐﮯ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﮐﮯ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨﮯ ﮐﮧ ﺗﺎ ﮨ
-
-
- . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
-
TLX: 486 209 SIVA IN Tamil Nadu, 5. India.
K9837998
Vadasery, Nagercoil-629001.
JAN 2 1 1999
| ﺮ | ﺎ | C | 1 | t | ||
|---|---|---|---|---|---|---|
| Q | ದ |
ពុក ខេ V រ ន E ប
KUMARS
FAX: 91 4652
" " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " "
SIAK SUMMARY as required by : 807.92(c) 1.0
APPI. ICANT . ે. - W NAME
, SKI ANUSHAM RUBBER INDUSTRIES (P) LTD PIONEER MANIKANDAN BUILDINGS VADASERRY, NAGERCOIL-629001 TAMIL NADU , 5.INDIA
: + 91 4652 23091 િમનભાયદ
: + 41 4652 328/1 t: UX
: MK. N.PARAMASIVAN CONINCT PERSON MANAGING DIRECTDR
DEVICE TRADE NAME : NIL
- : Patient fixamination Gloves-Powder Free COMMON NAME ર -
- I EGALLY MARKETED DEVICE TO WHICH বে এ CLAIMING EQUIVALENCE : COMPANAY
Class 1- Patient Examination Gloven(Powder Free) 90L YY the requirements of meets all that ASTM D 3578 - 95.
Type 1 - Gloves compounded primarily from Natural Rubber Latex.
DESCRIPTION OF THE DEVICE: S .
Llass 1- Patient Examination Gloves(Powder Free) ROL YY that meets all the requrements ASTM D 3578-95.
INTENDED USE DE THE DEVICE: ત
Lalex Examination Gloves (Powder Free) referred to as medical device are worn on hand and fingers by the examiner as effective barrier between examiner and patient against exposure to micro organism in blood and other body fluids, waste and equivilent.
PAGE ਉਰ
Page - 52
33091
32871
Page - 53
Pioneer Menikandan Buildings.
1
983998
7 . ហ
TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO PREDICATE DEVICE.
| Measured
by
SRI
TRIES PRIVATE LIMITED | Parameters of Latex
Surgeon's Gloves Manufactured
ANUSHAM RUBBER INDUS- | ASTM D 3578
Requirement for
Latex Examination
Glove-Powder free | |
|------------------------------------------------|-------------------------------------------------------------------------------|--------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Characteristics Size | Value | Value | Prescribed |
| 1. Length | Ex-S
S
M
L
Ex-L | 240-245mm
240-245mm
240-245mm
245-250mm
245-245mm | 220 mm minimum
220 mm minimum
230 mm minimum
230 mm minimum
230 mm minimum |
| 2. Width | Ex-S
S
M
L
Ex-L | 71mm
82mm
95mm
106mm
110mm | 70 +/- 6 mm
80 +/- 6 mm
95 +/- 6 mm
111 +/- 6 mm
114 +/- 6 mm |
| 3. Thickness | Ex-G
S
M
L
Ex-L | 0.11mm
0.12mm
0.12mm
0.10mm
0.11mm | 0.08 mm minimum
0.08 mm minimum
0.08 mm minimum
0.08 mm minimum
0.08 mm minimum |
PHYSICAL PROPERTICS
| CHARACTERISTICS | BEFORE AGEING | AFTER AGEING | ||
|---|---|---|---|---|
| *SARI VALUE | ASTM D 3578 REQUIREMENT | SARI VALUE | ASTM D 3578 REQUIREMENT | |
| Tensile Strength | 21-24 mpa | 14 mpa min. | 19-22mpa | 14 mpa min |
| Elongation at Break % | 800-850% | 700% min. | 700-800% | 500% min. |
| *SARI - SRI ANUSHAM RUBHER INDUSTRIES PRIVATE LIMITED |
2
KUMHAS VA-UA-YC
10
510 k. Submission
Application Page - 55
VU· 16
1877
4. 26
page 3/5
PERFORMANCE REULITHEMENT
| Characteristics | Related
Defects | Level
followed
By | | AQL
followed
by SARI | AQL Value
as per
ASTM D3578 |
|-----------------------|-------------------------------------------------------------------------------|-------------------------|-------------------------|----------------------------|-----------------------------------|
| | | SARI | As per
ASTM
D3578 | | |
| Freedom trom
Holes | Holes | S4 | S4 | 1.5 | 4 |
| Dimensions | Width
Length
Thickness | S2 | S2 | 4 | 4 |
| Physical
Property | Tensile
Strength
Elongation
at Break
before &
after
ageing. | S2 | S2 | 4 | 4 |
POWDER CONTENT:
| といってーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーー
| SARI VALUE | ASTN REDUIREMENT |
|---|---|
| ー・アーーンやー・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ | |
| 80 +1- 20 | 2mq/glove max |
| ーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーー |
PROTEIN CONTENT;
| SARI VALUE | FDA REQUIREMENT |
|---|---|
| イター・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ | |
| 80+1-20ppm | Value not fixed |
MO1STURE CONTENT :
| SARI VALUE | tores and commendent commendent ment compression consideration of the
FDA REQUIREMENT |
|------------|------------------------------------------------------------------------------------------|
| 0.4%. | Value not fixed
ャー・ページーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーー |
B I D--COMPA FAU IL I T Y
:
| といっても、このことになっても、その他のことになっている。このコーニングのないというということです。 ここで、
SARI GLUVE
| ーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーー | FDA REQUIREMENT |
|---|---|
| Biologically Compatible | |
| Look - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - | Biologically Compatible |
3
510 k Submission
Application Page - 56
K983998
Page 4/5
| 8.0 PERFORMANCE DATA | |||
|---|---|---|---|
| The Performance Test Data of the Powder Free Examination Gloves manufactured by SRI ANUSHAM RUBBER INDUSTRIES PVT LIMITED is given here-under: | |||
| Measured Parameters of Latex Examination Gloves (Powder Free) manufactured by SRI ANUSHAM RUBBER INDUSTRIES PRIVATE LIMITED | |||
| Characteristics | Size | Value | |
| 1. | Length | Ex-S | 240 - 245 mm |
| S | 240 - 245 mm | ||
| M | 240 - 245 mm | ||
| L | 245 - 250 mm | ||
| Ex-L | 245 - 250 mm | ||
| 2. | Width | Ex-S | 71mm |
| S | 82mm | ||
| M | 95mm | ||
| L | 106mm | ||
| Ex-L | 110mm | ||
| 3. | Thickness | Ex-S | 0.11mm |
| S | 0.12mm | ||
| M | 0.12mm | ||
| L | 0.10mm | ||
| Ex-L | 0.11mm |
PHYSICAL PROPERTIES
| CHARACTERISTICS | Before Ageing | After Ageing |
|---|---|---|
| Tensile Strength | 21-24 mpa | 19-22 mpa |
| Elongation at break % | 800-850% | 700- 800% |
:39
4
510 k Submission
Application Page - 57
08-08-92
page 5/5
06:19
| INSPECTION LEVEL OF AQL |
|---|
| ------------------------- |
| CHARACTERISTICS | RELATED DEFECTS | LEVEL | AQL |
|---|---|---|---|
| Freedom from holes | Holes | S4 | 1.5 |
| Dimensions | Length, Width & Thickness | S2 | 4 |
| Physical Properties | Tensile Strength | ||
| Elongation at Break before & after aging | S2 | 4 |
| POWDER CONTENT | 1 +/- 1 mg per glove |
|---|---|
| PROTEIN CONTENT | 80 +/- 20 ppm |
| MOISTURE CONTENT | 0.4% maximum |
| BI(J-COMPATABILITY | Biologically Compatible |
- ਾ ਹ CLINICAL DATA Not Applicable יי
CONCLUSION OF PERFURMANCE UF TEST DATA
The Powder Free Gloves manufactured by SRI ANUSHAM RUHBER INDUSTRIES PRIVATE LIMITED;
-
- Meet or excreed the ASTM DJ578-45 Specifications
-
- Meet FDA Pin Hole Requirements
-
- Meet Labelling Claim as shown in data under S.No.6
ANY UTHER INFORMATION:
Any other information required by FDA in respect of PRODUCT SAFETY AND EFFECTIVENESS shall be provided on demand.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three parallel lines above them, resembling a stylized bird or symbol of flight.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 1 1999
SRI Anusham Rubber Industries Pvt. Ltd. C/O Mrs. Latha Kumaraswamy P.O. Box 5206 Pleasanton, California 94566 USA
K983998 Re: Powder-Free Latex Examination Gloves Trade Name: Requlatory Class: I Product Code: Lyy Dated: November 4, 1998 Received: November 9, 1998
Dear Mrs. Kumaraswamy:
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 aqainst 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ರ್ಗ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 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.
6
Page 2 - Mrs. Kumaraswamy
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 diagnostic 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
Director
Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
510(k) Number (if known): K983998
Device Name: Powder Free Latex Examination Gloves
Indications For Use:
..............................................................................................................................................................................
. . .
3.1 INDICATIONS FOR USE
AFFLICANT SRI ANUSHAM RUBBER INDUSTRIES PVT.LTD t 510(K) NO 술술 DEVICE NAME POWDER FREE LATEX EXAMINATION GLOVES 1
INDICATIONS FOR USE:
Fowder Free Latex Examination Glove is a device intended for medical use , worn by the Examiner on his hands / fingers to prevent contamination between Patient and Examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Qus-L
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Dey 510(k) Number.
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)