(55 days)
Not Found
No
The device description and performance studies focus on the material properties and barrier function of a surgical glove, with no mention of AI or ML.
No
The device is a surgical glove intended to protect surgical wounds from contamination by forming a barrier, not to provide therapy or treatment.
No
The device is a surgical glove, intended to protect a surgical wound from contamination, not to diagnose a medical condition.
No
The device description clearly describes a physical product made of Natural Rubber Latex, intended to be worn on the hand. It details material properties, manufacturing standards, and performance tests related to a physical glove, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside of the body.
- Sensi Grip® Surgical Glove Function: The Sensi Grip® Surgical Glove is a barrier device worn on the hand during medical procedures. Its purpose is to protect the surgical wound from contamination and the wearer from body fluids and bloodborne pathogens. It does not analyze or test any specimens from the body.
The provided information clearly describes a surgical glove, which falls under the category of a Class II medical device (specifically, a surgical glove) and not an IVD.
N/A
Intended Use / Indications for Use
The Sensi Grip® Surgical Glove is a disposable device intended for medical use within hospitals and other healthcare facilities during invasive and non-invasive medical procedures requiring sterility. They are intended to be worn on the operating room personnel's hand to protect a surgical wound from contamination.
Product codes
KGO
Device Description
Natural Rubber Lates films form a barrier to body fluids and bloodborne pathogens. The latex rubber is water tight under normal conditions of use. It's tensile propertics cause it to conform to the hand, allowing movements necessary for a medical procedure. Natural Rubber Latex is known to create a barrier to bloodborne pathogens and and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The leaching and washing process removes traces of chemical accelerants That may be chemically irritating. The glove is manufactured in accordance with the Requirements of ASTM D3577-00 and ASTM D5151-99 requirements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room personnel's / hospitals and other healthcare facilities
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)
Non-clinical tests were performed based on ASTM D3577-00, ASTM D5151-99, and ASTM D5712-99 for performance standards, water tightness, and residual protein, respectively. Clinical tests were performed for safety (skin irritation) and skin sensitization. The results demonstrate that the proposed product satisfies and meets or exceeds acceptable selective powdered (with protein content label labeling and Made from Allotex an enzyme treated natural rubber latex claim) medical glove.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
[TAB #13]
Attachment #11
NOV 2 9 2001
Summary of 510(k) Submission
A. INFORMATION
- SUBMITTER'S l.
- NAME:
ADDRESS:
TELEPHONE NUMBER:
CONTACT PERSON:
DATE SUMMARY PREPARED:
- NAME OF DEVICE 2. TRADE OR PROPRIETARY NAME:
COMMON OR USUAL NAME:
CLASSIFICATION NAME:
TILLOTSON HEALTHCARE CORPORATION
360 Route 101 Bedford, NH 03110 U.S.A. (603) 472-6600
F.W. Perrella
September 2001
HPI Sensi Grip® Sterile Powdered Latex Surgical Glove, With labeled Protein Content and Made from Allotex® an Enzyme Treated Natural Rubber Latex
Surgical Glove
Surgical Glove
-
PREDICATE DEVICE IDENTIFICATION 3. NAME, NUMBER
HPI Ortho Surgeon's Glove (K894828) -
DESCRIPTION OF DEVICE 4. HOW THE DEVICE FUNCTIONS: a. Natural Rubber Lates films form a barrier to body fluids and bloodborne pathogens.
- SCIENTIFIC CONCEPTS THAT FORM THE BASIS FOR THE DEVICE: b. The latex rubber is water tight under normal conditions of use. It's tensile propertics cause it to conform to the hand, allowing movements necessary for a medical procedure.
- PHYSICAL AND PERFORMANCE CHARACTERISTICS SUCH AS DESIGN, C. MATERIALS AND PHYSICAL PROPERTIES: Natural Rubber Latex is known to create a barrier to bloodborne pathogens and and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The leaching and washing process removes traces of chemical accelerants That may be chemically irritating. The glove is manufactured in accordance with the Requirements of ASTM D3577-00 and ASTM D5151-99 requirements.
-
STATEMENT OF INTENDED USE, INCLUDING DESCRIPTION OF THE DISEASES OR న్. CONDITIONS THAT THE DEVICE WILL ADDRESS
- The Sensi Grip® Surgical Glove is a disposable device intended for medical use within hospitals and other healthcare facilities during invasive and non-invasive medical procedures requiring sterility. They are intended to be worn on the operating room personnel's hand to protect a surgical wound from contamination.
1
IIPI Sensi Grip® Sterile Powdered Latex Surgical Glove, With labeled Protein Content and Made from Allotex® an Enzyme Treated Natural Rubber Lates Submission Date: September 2001 11000 Number 1 0 3324
EXPLANATION OF SIMILARITIES OR DIFFERENCES TO PREDICATE DEVICE 6.
- XPLANATION OF SIMILANTIES ON DR LEAM and a raw material change whereby
O The modified product has a protein labeling claim to digest natural whiber la The modified product has a procent labeling claim and a ran a ran al rubber later proteins compared to the predicate product. - protems compared surgical glove in the same way as the prodicate product, but with protein It is a powdered surgical glove in the same wy and treated natural rubber lates claim.
B. IF THE DECISION BASED ON PERFORMANCE DATA
- DISCUSSION OF NON-CLINICAL TESTS -
| SPECIFICATION | PROPOSED
Powdered
(with protein content labeling and
Made from Allotex an enzyme
treated natural rubber latex claim) | PREDICATE
Powdered |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| PERFORMANCE
STANDARDS | ASTM D3577-00
Meets or Exceeds Requirements | ASTM D3577-91
Meets or Exceeds
Requirements |
| WATER TIGHTNESS | ASTM D5151-99
Meets or Exceeds Requirements | ASTM D5151-92
Meets or Exceeds
Requirements |
| RESIDUAL PROTEIN | ASTM D5712-99
Meets or Exceeds Requirements | |
DISCUSSION OF CLINICAL
TESTS
| SPECIFICATION | PROPOSED | PREDICATE |
|---|---|---|
| SAFETY | ||
| SKIN IRRITATION | Meets or Exceeds Requirements | Meets or Exceeds |
| Requirements | ||
| SKIN SENSITIZATION | Meets or Exceeds Requirements | Meets or Exceeds |
| Requirements |
CONCLUSIONS DRAWN FROM NONCLINICAL AND CLINICAL TESTS THAT 3. DEMONSTRATE DEMONSTRATE
The HPI Sensi Grip® Powdered Sterile Surgical Glove has been carefully compared to legally I hic HPT Schsi Orip® I owdered Sterne Burgens indicate that the proposed product marketed devices in the 310(k). The date sundicate product in nonclinical tests, and satisfies and meets of exceeds acceptable sective powdered (with protein content label labeling and Made from Allotex an enzyme treated natural rubber latex claim) medical glove.
Pursuant to 21 C.F.R. 807.87 ( j ), I, F.W. Perrella, Ph.D., Vice President R&D certify that to r ursuall to 21 C.I.IC 00107 ( J ) 4 2 x 2 x 2 x 2 x 2 and information submitted to me in the course of my responsibilities as the Vice President R&D for TILLOTSON me in the course of my respection, and in reliance thereupon, the data and information submitted in this of the substantial equivalence of this device have been knowingly omitted from this Submission.
F.W. Perrella, Ph.D.
Vice President R&D
2
Image /page/2/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 symbol that resembles three overlapping human figures or abstract shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 9 2001
Dr. Frank W. Perrella V.P. Research and Development Tillotson Healthcare Corporation 360 Route 101 W Bedford, New Hampshire 03110
Re: K013324
K013324
Trade/Device Name: HPI Sensi Grip Powdered Latex Surgical Gloves made from rade/Device Name. THP Poems Onp ber latex with a Protein Content Labeling Claim ( 50 Micrograms or Less per gram of glove) Regulation Number: 878.4460 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: KGO Dated: September 30, 2001 Received: October 5, 2001
Dear Dr. Perrella:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becases or self 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 interstate conmiseree prior to May 20, 20, 20, 20, 2017 accordance with the provisions of Amendinents, or to do roos that have onc (Act) that do not require approval of a premarket the rederal Pood, Drug, und Comment , 1994 - 1997 - 1997 - 1997 - 1994 - 1994 - 19 approvisions of the Act. The general controls provisions of the Act include controls provisions of the fict. From Jisting 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 If your device is classified (see as 10 10) in a controls. Existing major regulations affecting (1 Mrs), it may of back of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Seas nouncements concerning your device in the Federal Register.
3
Page 2 - Dr. Perrella
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618 . 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
[signature]
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
4
HPI Sensi Grip® Sterile Powdered Latex Surgical Glove, With labeled Protein Content and Made from Allotex® an Enzyme Treated Natural Rubber Lates Submission Date: September 2001 510(k) Number: (013324
- Indications for Use Statement: Include the following or equivalent Indications for Use page 3.0 The information, data and labeling claims in the entire the 510(k) submission must support and agree with the Indications for Use statement.
INDICATIONS FOR USE
| Applicant: | Tillotson Healthcare Corporation |
|---|---|
| 5 10(k) Number (if known):* | |
| Device Name: | HPI Sensi Grip® Sterile Powdered Latex Surgical Glove, With labeled |
| Protein Content and Made from Allotex® an Enzyme Treated Natural | |
| Rubber Latex ( 50 MICROGRAMs or less) | |
| Indications For Use: | The Sensi Grip® Surgical Glove is a disposable device intended for |
| medical use within hospitals and other healthcare facilities during | |
| invasive and non-invasive medical procedures requiring sterility. | |
| They are intended to be worn on the operating room personnel's |
hand 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)
Qlin Si Lim
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital. Dev 510(k) Number
Prescription Use OR Over-The-Counter _ Per 21 CFR 801.109 (Optional Format 1-2-96)
For a new submission, do NOT fill in the 510(k) number blank.