LogoFDA 510(k) Search
K Number
K982589
Device Name
SURGEON'S GLOVE
Manufacturer
SHIVA MEDICARE LTD.
Date Cleared
1998-09-10

(48 days)

Product Code
KGO
Regulation Number
878.4460
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Surgeon's glove is a medical device intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
Class I Surgeon's Glove 79KGO powdered with Absorbable Dusting Powder that meets all 'the requirements of ASTM D3577.
More Information

K982589

Not Found

No
The 510(k) summary describes a standard surgeon's glove and its physical and performance characteristics, with no mention of AI or ML technology.

No.
The intended use of the surgeon's glove is to protect a surgical wound from contamination, which is a preventive measure rather than a therapeutic one (treating or alleviating a disease/condition).

No
The "Intended Use" states that the device is a glove worn by operating room personnel to protect a surgical wound from contamination, which is a protective and barrier function, not a diagnostic one.

No

The device description clearly states it is a physical surgeon's glove, a hardware component, and the performance studies focus on physical properties and material characteristics.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to "be worn by operating room personnel to protect a surgical wound from contamination." This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
  • Device Description: It's described as a "Surgeon's Glove," which is a physical barrier device.
  • Lack of IVD Characteristics: There is no mention of:
    • Analyzing samples (blood, urine, tissue, etc.)
    • Detecting or measuring substances in samples
    • Providing information for diagnosis, monitoring, or screening

The performance data provided relates to the physical properties and safety of the glove itself (strength, dimensions, freedom from holes, powder content, etc.), which are relevant for a medical device intended for physical protection, not for in vitro diagnostic testing.

N/A

Intended Use / Indications for Use

Surgeon's glove is a medical device intended to be worn by operating room personnel to protect a surgical wound from contamination.

Product codes (comma separated list FDA assigned to the subject device)

KGO

Device Description

Class I Surgeon's Glove 79KGO powdered with Absorbable Dusting Powder 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 surgeons gloves manufactured by Shiva Medicare Limited is given below.

Measured Parameters if Latex Surgeon's gloves (Powder free) manufactured by Shiva Medicare Ltd.,

CharacteristicsSIZEValue
  1. Length | 5 ½ | 270 mm
    | 6 | 270 - 272mm
    | 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 | 68mm
    | 6 | 73mm
    | 6 ½ | 79mm
    | 7 | 87mm
    | 7 ½ | 92mm
    | 8 | 103mm
    | 8 ½ | 106mm
    | 9 | 112mm

Thickness at cuff , Palm and finger tip of all the size is 0 .12, 0.16 and 3. 0.19. mm.

PHYSICAL PROPERTIES:

CharactersticsBefore AgeingAfter Ageing
Tensile Strength27 mpa20 mpa
Elongation at break %850%750%
Modulus at 500 % elongation.3 mpa-

PERFORMANCE REQUIREMENT:

CharacteristicsRelated defectsLEVELAQL
SterilityFails sterilityAs per Indian Pharmacopea
Freedom from HolesHolesS41.5
DimensionWidth , Length Thickness.S24
Physical PropertyTensile strength , Elongation at break before and after ageing.S24

POWDER CONTENT : 120 +/- 20
PROTEIN CONTENT: 80 +/- 20 ppm
MOISTURE CONTENT: 0.8% max
BIOCOMPATABILITY: Biologically Compatable.

CONCLUSION OF PERFORMANCE TEST DATA:
The Surgeon's gloves manufactured by Shiva Medicare Limited

  • Meet or exceed the ASTM D3577
  • Meet FDA Pin hole Requirement. -
  • Meet labelling claim as shown by the data in 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.

K982589

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

SEP 1 0 1998

Image /page/0/Picture/1 description: The image shows a logo for Shiva. The logo consists of a black triangle with a white "S" shape inside. Below the triangle, the word "SHIVA" is written in a bold, sans-serif font. The logo is simple and modern, with a focus on the geometric shape and the company name.

71

  1. 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/
FAX NO: 91-44-2368327
EMAIL: shivam@md2.vsnl.net.in
CONTACT PERSON: MR. SATISH JAIN
EXECUTIVE DIRECTOR.
3. DEVICE TRADE NAME: NIL
COMMON NAME: Surgeon's Glove
Classification Name: Surgeon's Glove
    1. Legally marketed device to which the company claiminng equivalence: Class I Surgeon's Glove 79KGOthat meets all the requirements of ASTM D3577.
    1. DESCRIPTION OF THE DEVICE :

Class I Surgeon's Glove 79KGO powdered with Absorbable Dusting Powder that meets all 'the requirements of ASTM D3577.

Intended use of the Device: 6.0

Surgeon's glove is a Medical Device intended tobe worn by Operating room personnel to protect a surgical wound from contamination.

Image /page/0/Picture/10 description: The image shows the logo for Shiva Medicare Limited. The logo includes a plus sign with the word "Medicare" written diagonally across it. Below the company name is the text "(A 100% Export Oriented Unit)".

Registered Office & Works : A 15-17, M.E.P.Z., Kadaperi, Tambaran, Chennai - 600 043 (INDIA) Phones : 044/2368011/2368322 EMAIL: 5 hivan @md2.vsnl-net.in Telefax : 091-44-2368327. Grams : "SHIVMEDI Cornorate Office : 808, Pragati Tower, 26, Rajendra Place, New Delhi - 110 008 (INDIA)

1

K982589

$P^{2/5}$ $^{72}$

  • 7.0 Technological characteristics of the device compared to predicate device.

| Measured Parameters of Latex
Surgeon's Glove manufactured by Shiva
Medicare Ltd., | | | ASTMD3577
Requirement for
Latex Surgeons glove |
|-----------------------------------------------------------------------------------------|------|-------------|------------------------------------------------------|
| Characteristics | SIZE | Value | |
| 1. Length | 5 ½ | 270- 272 mm | 245 mm minimum |
| | 6 | 270-272mm | 265 mm minimum |
| | 6 ½ | 270-272mm | 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 +/- 6 mm |
| | 6 ½ | 79 mm | 83 +/- 6mm |
| | 7 | 87mm | 99 +/- 6mm |
| | 7 ½ | 92mm | 95 +/- 6mm |
| | 8 | 103mm | 105+/- 6mm |
| | 8 ½ | 106mm | 108+/- 6mm |
| | 9 | 112mm | 114 +/- 6mm |

  • Thickness at cuff , Palm and finger tip of all the size is 0 .12,0 .16 and 3. I hickness at curr, Failf and imger tip of all atthess specified at cuff palm and finger tip is 0.1 mm.
    PHYSICAL PROPERTIES:
BEFORE AGEINGAFTER AGEING
CharacteristicsSML ValueASTM
D3577SML ValueASTD 3577
Requirement
Tensile Strength
Elongation at break %27 mpa24 mpa (min)
750%20 mpa
750%18 mpa min
560% min
Modulus at 500 %
elongation3 mpa5.5 mpa
(max)--

Image /page/1/Picture/6 description: The image shows a circular stamp with the words "SHIVA MEDICAL" around the top half of the circle. In the center of the circle are the words "Madras-600 045." There is a star on the left side of the circle.

2

73
K982589
P3/5

PERFORMANCE REQUIREMENT:

| Characteristics | Related defects | Level Followed | | AQL
followed | AQL as per
ASTM D3577. |
|-----------------------|-------------------------------------------------------------------------------|----------------|------------|-----------------|---------------------------|
| | | SML | ASTM D3577 | | |
| Sterility | Fails sterility | As per IP | Asper USP | NA | NA |
| Freedom from
Holes | Holes | S4 | | 1.5 | 1.5 |
| Dimension | Width, Length
Thickness. | S2 | S4 | 4 | 4 |
| Physical
Property | Tensile
strength,
Elongation at
break before
and after
ageing. | S2 | S2 | 4 | 4 |

POWDER CONTENT

Class of the first for the proposal and a property and the program and the programAND A BOLL CONSULTION OF CHILINGS OF COLLEGION OF COLLEGIONAL CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF
Contract of Children Comments of Children Commendent Commend Comments of Children------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
SML VALUE------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ASTM REQUIREMENT
" would be the program and the first and the commend of the county ofAnnual Party of Controller of Concession of Concession Company of Concession of Concession of Concession of Concession of Concession of Concession of Concession of Concession
Comments of the controlled by the first of the first and the first and
20
120 +/-
The state of the state of the state of the same of the same of the same of the same of the see andA
Comments of Actively more and the became of the many of the may be any and the comments of the comments of the count

PROTEIN CONTENT:

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ーー
SML VALUEFDA REQUIREMENT
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
www.comment.com/sport/space/article/space/a/memore/sport/arm-sological/sport/arm-
80 +/- 20 ppm------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Value not fixed.
Comments of the contract and the control of the contribution of the status and the status and the status and the status of the status of the status and

MOISTURE CONTENT:

| and the first and the many of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of
SML VALUE | - All Child Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children
STATUTE OF CLEASE OF COLLECTION OF CLEASE OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF CLEASURES OF COLLECTION OF COLLECTION OFFICE OF COLLECTION
FDA REQUIREMENT |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| with the state of the many of the many of the many of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comm
0.8% max
In the superior for the first and the provinced and commended of the provinces on the relation of the management of the many of the many of the many of the many of the many o | No value fixed |

BIOCOMPATABILITY:

| Comments of the contraction of the commended to the compressional consistence and consistences and consistences and consistences and consistences and consistences and consist

SML GLOVEFDA REQUIREMENT
Biologically Compatable
Annual property of the first of the "luck"Biologically Compatable

Image /page/2/Picture/11 description: The image shows a circular stamp with the words "SHIVA MEDICARE" around the top edge. In the center of the stamp, the word "Madras" is written above the number "600 045.". The stamp appears to be slightly tilted.

3

K982589
p$^{4/5}$

Price

8.0 Performance Data:

The performance test data of the surgeons gloves manufactured by Shiva Medicare Limited is given below.

Measured Parameters if Latex
Surgeon's gloves (Powder free)
manufactured by Shiva Medicare Ltd.,
CharacteristicsSIZEValue
1. Length5 ½270 mm
6270 - 272mm
6 ½270 – 272 mm
7270 - 272 mm
7 ½270 -272 mm
8270 -272 mm
8 ½270 – 272 mm
9270 – 272 mm
2. Width5 ½68mm
673mm
6 ½79mm
787mm
7 ½92mm
8103mm
8 ½106mm
9112mm
  • Thickness at cuff , Palm and finger tip of all the size is 0 .12, 0.16 and 3. 0.19. mm.

PHYSICAIL PROPERTIES:

CharactersticsBefore AgeingAfter Ageing
Tensile Strength27 mpa20 mpa
Elongation at break %850%750%
Modulus at 500 %
elongation.3 mpa-

4

K98 2589
P 515

PERFORMANCE REQUIREMENT:

CharacteristicsRelated defectsLEVELAQL
SterilityFails sterilityAs per Indian
Pharmacopea
Freedom from
HolesHolesS41.5
DimensionWidth , Length
Thickness.S24
Physical
PropertyTensile
strength ,
Elongation at
break before
and after
ageing.S24

POWDER CONTENT : 120 +/ - 20

PROTEIN CONTENT: 80 +/- 20 ppm

MOISTURE CONTENT: 0.8% max

BIOCOMPATABILITY: Biologically Compatable.

NA 9. Clinical Data "

10. CONCLUSION OF PERFORMANCE TEST DATA:

The Surgeon's gloves manufactured by Shiva Medicare Limited

  • Meet or exceed the ASTM D3577 ﺴ
  • Meet FDA Pin hole Requirement. -
  • Meet labelling claim as shown by the data in 6 -

11. ANY OTHER INFORMATION:

Any other information required by FDA regarding product safety and effectiveness will be provided on request.

Image /page/4/Picture/15 description: The image shows a circular stamp with the words "SHIVA MEDICALS" written along the top arc. The words "Madras - 600 045." are written in the center of the stamp. The stamp appears to be black ink on a white background.

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 stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circle's perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 1998

M/s. Shiva Medicare Ltd. C/O Mr. James F. Logan Medical Reports Exchange 314 North Hunter Street Baltimore, MD 21202

Re: K982589 Trade Name: Surgeon's Glove, Latex Powdered Free Regulatory Class: I Product Code: KGO Dated: June 30, 1998 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 general 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 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,

S. Butman 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:

APPLICANTSHIVA MEDICARE LIMITED
510(K) No.K982589
DEVICE NAMESURGEON'S GLOVE

INDICATIONS FOR USE:

Prescription Use

(Pct 21 CFR 801.109)

Surgeon's glove is a medical device intended to be worn by operating room personnel 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)

OROver-The-Counter Use
--------------------------
Neure 1. Meir fer
(Division Sign-Off)Ulin S. Zin, PhD
Division of Dental, Infection Control, and General Hospital Devices(Optional Format 1-2-96)
510(k) NumberK982588
------------------------