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.

Device Description

Natural Rubber Latex films form a barrier to body fluids and bloodborne pathogens. The latex rubber is water tight under normal conditions of use. It's tensile properties 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.

AI/ML Overview

{
  "1. A table of acceptance criteria and the reported device performance": {
    "Non-Clinical Tests": {
      "SPECIFICATION": [
        "PERFORMANCE STANDARDS",
        "WATER TIGHTNESS",
        "RESIDUAL PROTEIN"
      ],
      "ACCEPTANCE CRITERIA (Proposed Powdered Glove)": [
        "ASTM D3577-00: Meets or Exceeds Requirements",
        "ASTM D5151-99: Meets or Exceeds Requirements",
        "ASTM D5712-99: Meets or Exceeds Requirements"
      ],
      "REPORTED DEVICE PERFORMANCE (Proposed Powdered Glove)": [
        "Meets or Exceeds Requirements",
        "Meets or Exceeds Requirements",
        "Meets or Exceeds Requirements"
      ],
      "PREDICATE DEVICE PERFORMANCE": [
        "ASTM D3577-91: Meets or Exceeds Requirements",
        "ASTM D5151-92: Meets or Exceeds Requirements",
        "Not applicable (predicate did not have a protein labeling claim)"
      ]
    },
    "Clinical Tests": {
      "SPECIFICATION": [
        "SAFETY: SKIN IRRITATION",
        "SKIN SENSITIZATION"
      ],
      "ACCEPTANCE CRITERIA (Proposed Powdered Glove)": [
        "Meets or Exceeds Requirements",
        "Meets or Exceeds Requirements"
      ],
      "REPORTED DEVICE PERFORMANCE (Proposed Powdered Glove)": [
        "Meets or Exceeds Requirements",
        "Meets or Exceeds Requirements"
      ],
      "PREDICATE DEVICE PERFORMANCE": [
        "Meets or Exceeds Requirements",
        "Meets or Exceeds Requirements"
      ]
    }
  },
  "2. Sample sized used for the test set and the data provenance": "The document does not explicitly state the sample sizes used for the non-clinical and clinical tests. It only refers to meeting or exceeding ASTM standards and general safety requirements. The data provenance is implied to be from tests conducted by the manufacturer, Tillotson Healthcare Corporation, in the USA.",
  "3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts": "Not applicable. This is a medical device submission for surgical gloves, not a diagnostic device requiring expert interpretation of results to establish ground truth.",
  "4. Adjudication method for the test set": "Not applicable. This is a medical device submission for surgical gloves, not a diagnostic device requiring adjudication of results.",
  "5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance": "Not applicable. This is a medical device submission for surgical gloves, not an AI-assisted diagnostic tool.",
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Not applicable. This is a medical device submission for surgical gloves, not an AI algorithm.",
  "7. The type of ground truth used": "For non-clinical tests (Performance Standards, Water Tightness, Residual Protein), the 'ground truth' is defined by adherence to established ASTM standards (D3577-00, D5151-99, D5712-99). For clinical tests (Skin Irritation, Skin Sensitization), the 'ground truth' is implied to be established through standard safety evaluations demonstrating the glove meets or exceeds safety requirements.",
  "8. The sample size for the training set": "Not applicable. This is a medical device submission for surgical gloves, not a machine learning model requiring a training set.",
  "9. How the ground truth for the training set was established": "Not applicable. This is a medical device submission for surgical gloves, not a machine learning model."
}

Summary

{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

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	PROPOSEDPowdered(with protein content labeling andMade from Allotex an enzymetreated natural rubber latex claim)	PREDICATEPowdered
PERFORMANCESTANDARDS	ASTM D3577-00Meets or Exceeds Requirements	ASTM D3577-91Meets or ExceedsRequirements
WATER TIGHTNESS	ASTM D5151-99Meets or Exceeds Requirements	ASTM D5151-92Meets or ExceedsRequirements
RESIDUAL PROTEIN	ASTM D5712-99Meets or Exceeds Requirements

DISCUSSION OF CLINICAL
TESTS

SPECIFICATION	PROPOSED	PREDICATE
SAFETYSKIN IRRITATION	Meets or Exceeds Requirements	Meets or ExceedsRequirements
SKIN SENSITIZATION	Meets or Exceeds Requirements	Meets or ExceedsRequirements

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 labeledProtein Content and Made from Allotex® an Enzyme Treated NaturalRubber Latex ( 50 MICROGRAMs or less)
Indications For Use:	The Sensi Grip® Surgical Glove is a disposable device intended formedical use within hospitals and other healthcare facilities duringinvasive 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.

Regulation Number and Section

§ 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).