(18 days)
79KGO
Not Found
No
The device description and performance studies focus on the physical properties and regulatory compliance of a surgical glove, with no mention of AI or ML technologies.
No
The device is described as a medical device intended to protect a surgical wound from contamination, not to treat or cure a disease or condition. It acts as a barrier, which is a protective function rather than a therapeutic one.
No
The device is a surgical glove, which is a protective barrier, not a tool for diagnosing medical conditions. Its intended use is to protect a surgical wound from contamination.
No
The device is a physical surgical glove, not software. The summary describes physical properties and performance testing of a tangible product.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the glove is "intended to be worn by operating room personnel to protect a surgical wound from contamination." This is a barrier device used during a medical procedure, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description identifies it as a "Class I Powder free Surgical Glove." Surgical gloves are considered medical devices, but not IVDs.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVDs, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring analytes
The information provided describes a physical barrier device used in a surgical setting.
N/A
Intended Use / Indications for Use
Powder free Surgeon's glove is a sterile powder free medical device intended to be worn I oncer free bargen ersonnel to protect a surgical wound from contamination.
Product codes (comma separated list FDA assigned to the subject device)
KGO
Device Description
Class I Powder free Surgical Glove 79KGO that meets all the requirements of ASTM D3577.
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
Operating room personnel
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 surgical gloves manufactured by Shiva Medicare Limited is given below.
Measured Parameters of Latex Surgeon's gloves (Powder free) manufactured by Shiva Medicare Ltd., Characteristics, SIZE, Value (Length, Width, and Thickness at cuff, Palm and finger tip).
PHYSICAL PROPERTIES: Characteristics (Tensile Strength, Elongation at break %, Modulus at 500 % elongation) Before Ageing and After Ageing.
PERFORMANCE REQUIREMENT: Characteristics (Sterility, Freedom from Holes, Dimension, Physical Property)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics presented are: Length, Width, Thickness, Tensile Strength, Elongation at break %, Modulus at 500 % elongation, AQL for Freedom from Holes, Dimension, Physical Property, Powder Content, Protein Content, Moisture Content, and Biocompatibility.
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.
Class I Surgeon's Glove ( Powder free) 79KGOthat meets all the requirements of ASTM D3577.
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
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).
0
AUG | | | 1998
Image /page/0/Picture/1 description: The image shows a close-up of handwritten numbers and a letter. The numbers "98" and "2586" are visible, along with the letter "K". A horizontal line is drawn beneath the numbers, possibly indicating a total or a separation of values. The handwriting appears to be done with a thick marker or pen, giving the characters a bold and somewhat rough texture.
Image /page/0/Picture/2 description: The image shows a logo with a triangular shape at the top and the word "SHIV" written below it. The triangle is filled with a dark color, and there is a white letter "S" inside the triangle. The word "SHIV" is written in bold, uppercase letters.
:17
- 510K SUMMARY as required by: 807.92( c )
1.0 APPLICANT
| NAME | M/s. SHIVA MEDICARE LIMITED |
|---|---|
| ADDRESS | A 15, 16, 17(PART) |
| MADRAS EXPORT PROCESSINGZONE | |
| KADAPERI, TAMBARAM, | |
| CHENNAI 600 045. | |
| INDIA. | |
| PH.NO. | : 91-44-2368011/2368322/2362656/2362657. |
| FAX NO | : 91-44-2368327 |
| : shivam@md2.vsnl.net.in |
CONTACT PERSON: MR. SATISH JAIN EXECUTIVE DIRECTOR.
- DEVICE TRADE NAME : NIL
.. Surgeon's Glove COMMON NAME
: Powder free Surgeon's Glove Classification Name
-
- Legally marketed device to which the company claiming equivalence: Class I Surgeon's Glove ( Powder free) 79KGOthat meets all the requirements of ASTM D3577.
-
- DESCRIPTION OF THE DEVICE :
Class I Powder free Surgical Glove 79KGO that meets all the requirements of ASTM D3577.
Intended use of the Device: 6.0
Powder free Surgeon's glove is a Powder free Medical Device intended tobe worn by Operating room personnel to protect a surgical wound from contamination.
Image /page/0/Picture/15 description: The image shows a logo for Shiva Medicare LTD. The logo features a black cross with the word "MEDICARE" written diagonally across it. Below the cross is a circular seal with the words "SHIVA MEDICARE LTD" around the edge and "Madras-600 045" in the center.
Shiva Medicare Limited
(A 100% Export Oriented Unit)
Registered Office & Works : A 15-17. M.E.P.Z., Kadaperi, Tambaram, Chenna1 - 600 045 (INDIA) Phones : 044/2368011/2368322 EMAIL: Shivani @md2.vsnl-net.in Telefax : 091-44-2368327. Grams : "SHIVMEDI" Corporate Office : 808, Pragaii Tower, 26, Rajendra Place, New Delhi - 110 008 (INDIA) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
1
7.0 Technological characteristics of the device compared to predicate device.
| Measured Parameters of Latex
Surgeon's gloves (Powder free)
manufactured by Shiva Medicare Ltd., | | | ASTM D3577
Requirement for
Latex Surgeon's glove
(Powder free) |
|--------------------------------------------------------------------------------------------------------|------|---------------|-------------------------------------------------------------------------|
| Characteristics | SIZE | Value | |
| 1. Length | 5 ½ | 270-272 mm | 245 mm minimum |
| | 6 | 270 – 272 mm | 265 mm minimum |
| | 6 ½ | 270 - 272 mm | 265 mm minimum |
| | 7 | 270 - 272 mm | 265mm minimum |
| | 7 ½ | 270 –272 mm | 265 mm minimum |
| | 8 | 270 -272 mm | 265 mm minimum |
| | 8 ½ | 270 -- 272 mm | 265 mm minimum |
| | 9 | 270 - 272 mm | 265 mm minimum |
| 2. Width | 5 ½ | 68 mm | 70 +/- 6 mm |
| | 6 | 73mm | 76 +/- 6mm |
| | 6 ½ | 79mm | 83 +/- 6 mm |
| | 7 | 87mm | 99 +/- 6 mm |
| | 7 ½ | 92mm | 95 +/- 6 mm |
| | 8 | 103mm | 105+/- 6 mm |
| | 8 ½ | 106mm | 108+/-6 mm |
| | 9 | 112mm | 114+/-6 mm |
-
- Thickness at cuff , Palm and finger tip of all the size is 0 .12, 0 .16 and 0.19mm.
ASTM D3577 requirement for thickness at cuff, palm and finger tip is 0.1 mm minimum.
- Thickness at cuff , Palm and finger tip of all the size is 0 .12, 0 .16 and 0.19mm.
PHYSICAL PROPERTIES:
| BEFORE AGEING | AFTER AGEING | |||
|---|---|---|---|---|
| Characteristics | SML Value | ASTM | ||
| D3577 | ||||
| Requirement | SML Value | ASTM | ||
| D3577 | ||||
| Requirement | ||||
| Tensile Strength | 27 mpa | 24 mpa | 20 mpa | 18 mpa min |
| Elongation at break % | 850% | 750% | 750% | 560% min |
| Modulus at 500 % | ||||
| elongation. | 3 mpa | 5.5 mpa | ||
| (max) | - | - |
Image /page/1/Picture/6 description: The image shows a circular stamp with the words "AAIHA MEDICARE LTD" around the outer edge. Inside the circle, the text "Madras-600 045" is visible. The stamp appears to be somewhat faded or worn, giving it a vintage or official document-like appearance.
2
ERFORMANCE REQUIREMENT:
| Characteristics | Related
defects | Level followed
By
SML | Level As
per ASTM
D 3577 | AQL followed | AQL as per ASTM
D3577. |
|-----------------------|-------------------------------------------------------------------------------|-----------------------------|--------------------------------|--------------|---------------------------|
| Sterility | Fails sterility | As per IP* | As per
USP*. | NA | NA |
| Freedom from
Holes | Holes | S4 | S4 | 1.5 | 1.5 |
| Dimension | Width ,
Length
Thickness. | S2 | S2 | 4 | 4 |
| Physical
Property | Tensile
strength ,
Elongation at
break before
and after
ageing | S2 | S2 | 4 | 4 |
IP – INDIAN PHARMACOPEA
OWDER CONTENT
| CIT 57
ﻟ
STATUTE OF COLUMN | ARFOURFMENT
A C'T'T |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Nil P
Powder
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | mo/olove
max |
PROTEIN CONTENT:
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
CONTINE
| 1 - 1 - 1 | DE CITIENTT |
|---|---|
| 00 | |
| mmm | |
| Actually College | |
| A & Acres and assessment compares | |
| of the property of the a second and in any of | |
| Property of Canadian College of Children | alue not fixed. |
| STATUTE OF COLUMN OF CHEARTH AND THE PERSONAL PROPERTY |
MOISTURE CONTENT:
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
THE PHONOR A - A - A 16 - 415 - 411 - 411 - 411 - 411 - 411 - 411 - 411 - 411 - 411 - 411 - 411 - 411 - 411 - 411 - 411 - 411 - 411 - 411 - 411 - 411 - 411 - 411 - 411 - 411
A STATUS MARK VITE THE THE STORE THE
דיין
AN VALUE
A bear and and all different the later the later the later than | דיד גדוד לוח לה במוז
TY-13
TT
1
-
|
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 00
mau
11 1641
and and and the proposed for at the first can a first a program and | CMILD
TIVAC
www.bandrer and the transmit of the company of the company of the company of the company of the first to the country of the first to the company of the company of the first t |
BIOCOMPATABILITY:
| SML GLOVE | FDA REQUIREMENT |
|---|---|
| Biologically Compatible | Biologically Compatible |
Image /page/2/Picture/11 description: The image shows a circular stamp with the text "SHIVA MEDICARE LTD" around the border. In the center of the stamp, the text "Madras-600 045" is visible. The stamp appears to be of low quality, with some blurring and distortion.
3
8.0. Performance Data:
The performance test data of the powder free surgical gloves manufactured by Shiva Medicare Limited is given below.
| Measured Parameters of Latex | ||
|---|---|---|
| Surgeon's gloves (Powder free) | ||
| manufactured by Shiva Medicare Ltd., | ||
| Characteristics | SIZE | Value |
| 1. Length | 5 ½ | 270 – 272 mm |
| 6 | 270 – 272 mm | |
| 6 ½ | 270 – 272 mm | |
| 7 | 270 – 272 mm | |
| 7 ½ | 270 – 272 mm | |
| 8 | 270 – 272 mm | |
| 8 ½ | 270 – 272 mm | |
| 9 | 270 – 272 mm | |
| 2. Width | 5 ½ | 68 mm |
| 6 | 73 mm | |
| 6 ½ | 79 mm | |
| 7 | 87 mm | |
| 7 ½ | 92 mm | |
| 8 | 103 mm | |
| 8 ½ | 106 mm | |
| 9 | 112 mm |
-
- Thickness at cuff , Palm and finger tip of all the size is 0 .12, 0.16 and 0.19 mm.
PHYSICAL PROPERTIES:
- Thickness at cuff , Palm and finger tip of all the size is 0 .12, 0.16 and 0.19 mm.
| Characteristics | Before Ageing | After Ageing |
|---|---|---|
| Tensile Strength | 27 mpa | 20 mpa |
| Elongation at break % | 850% | 750% |
| Modulus at 500 % | ||
| elongation. | 3 mpa | - |
Image /page/3/Picture/6 description: The image shows a circular stamp with the text "SHIVA MEDICARE LTD" around the outer edge. Inside the circle, the text "Madras-600 045" is printed. The text is in a simple, sans-serif font and is arranged in a way that it fills the circular space effectively. The stamp appears to be somewhat worn, with some parts of the text slightly faded or smudged.
4
PERFORMANCE REQUIREMENT:
| Characteristics | Related defects | LEVEL | AQL |
|---|---|---|---|
| Sterility | Fails sterility | As per Indian | |
| Pharmacopea | |||
| Freedom from | |||
| Holes | Holes | S4 | 1.5 |
| Dimension | Width , Length | ||
| Thickness. | S2 | 4 | |
| Physical | |||
| Property | Tensile | ||
| strength , | |||
| Elongation at | |||
| break before | |||
| and after | |||
| ageing. | S2 | 4 |
POWDER CONTENT : 1 + /- 1 mg per Glove
PROTEIN CONTENT: 80 +/- 20 ppm
MOISTURE CONTENT: 0.8 % max
BIOCOMPATABILITY: Biologically Compatible
NA 9. Clinical Data :
- CONCLUSION OF PERFORMANCE TEST DATA:
The Powder free Surgeon's gloves manufactured by Shiva Medicare Limited
Meet or exceed the ASTM D3577 -
- Meet FDA Pin hole Requirement. -
- Meet labeling claim as shown by the data in 6 -
- ANY OTHER INFORMATION:
Any other information required by FDA regarding product safety and effectiveness will be provided on request.
Image /page/4/Picture/14 description: The image shows a circular seal with the text "AHIA MEDICARE LT" around the outer edge. Inside the circle, the text "Madras-600 045" is printed. The text is in a simple, sans-serif font and is arranged to fit within the circular shape of the seal. The seal appears to be a stamp or an official mark, possibly from a medical or healthcare-related organization located in Madras (now Chennai), India.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, with a wing-like shape extending from the head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG | | 1998
M/s. Shiva Medicare Ltd. C/O Mr. James F. Logan Medical Reports Exchange 314 N Huntet Street Baltimore, Maryland 21202
Re : K982586 Sterile Powder-Free Surgical Glove, Trade Name: Disposable Regulatory Class: I Product Code: KGO July 24, 1998 Dated: Received: July 24, 1998
Dear Mr. Logan:
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 qeneral controls provisions of the Act. 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.
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. A 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 regulation 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
6
Page 2 - Mr. Logan
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 regulation (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 qeneral 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,
S. Dutram for
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
3.0 INDICATIONS FOR USE:
| APPLICANT | SHIVA MEDICARE LIMITED |
|---|---|
| 510(K) No. | K98 2586 |
| DEVICE NAME | POWDER FREE SURGEON'S GLOVE |
INDICATIONS FOR USE:
Powder free Surgeon's glove is a sterile powder free medical device intended to be worn I oncer free bargen ersonnel to protect a surgical wound from contamination.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Qim S. L
Division Sign. 280
Division Sign-( iff) Division of Der. Infection Control, ind General Hospital Devices "10(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use X
(Optional Format 1-2-9