GRI single use drapes (both sterile and non-sterile) are made of natural or synthetic material intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.

Non-sterile GRI surgical drapes are sold, in bulk as single use items, to repackager/relabeler establishments for further packaging and ethylene oxide (EtO) sterilization.

GRI single use surgical equipment covers (both sterile and non-sterile) are protective barrier covers intended to be used to cover surgical equipment and provide a protective barrier for that equipment.

Non-sterile GRI surgical equipment covers are sold, in bulk as single use items, to repackager/relabeler establishments for further packaging and ethylene oxide (EtO) sterilization.

Device Description

GRI's single use drapes and surgical equipment covers with AAMI Liquid Barrier Level 3 claim are constructed with various base sheet fabric and reinforcement fabric types, provided in various sizes and shapes, and may contain fluid collection pouches or clear film panels as components. The base sheet fabric is a three layer laminate comprised of polypropylene spunbond/polypropylene mettblown/polypropylene spunbond. Layers are thermally embossed together producing a single layer with various basis weights. Fabric is topically treated to enhance water repellency and to assure static dissipation. The drape reinforcement fabrics are constructed of various configurations of spunbond, meltblown and film. The reinforcement materials are spunbond/film laminate. The primary component of these materials is polypropylene with surfactant and blue pigment.

AI/ML Overview

Based on the provided text, here's a detailed breakdown of the acceptance criteria and the study for the GRI Sterile and Non-Sterile Surgical Drapes and Surgical Equipment Covers:

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Characteristic	Acceptance Criteria	Reported Device Performance
Material Properties:
Biocompatibility:	Not explicitly stated, but "met acceptance criteria" and "substantially equivalent to predicate devices" implies compliance with relevant standards.	Cytotoxicity: Met acceptance criteria Primary Skin Irritation: Met acceptance criteriaSensitization: Met acceptance criteria
Hydrostatic Pressure	Not explicitly stated, but "met acceptance criteria" and "substantially equivalent to predicate devices" implies compliance with relevant standards.	Met acceptance criteria
Impact Penetration	Not explicitly stated, but "met acceptance criteria" and "substantially equivalent to predicate devices" implies compliance with relevant standards.	Met acceptance criteria
Tear Strength	Not explicitly stated, but "met acceptance criteria" and "substantially equivalent to predicate devices" implies compliance with relevant standards.	Met acceptance criteria
Tensile Strength	Not explicitly stated, but "met acceptance criteria" and "substantially equivalent to predicate devices" implies compliance with relevant standards.	Met acceptance criteria
Linting	Not explicitly stated, but "met acceptance criteria" and "substantially equivalent to predicate devices" implies compliance with relevant standards.	Met acceptance criteria
Flammability	Not explicitly stated, but "met acceptance criteria" and "substantially equivalent to predicate devices" implies compliance with relevant standards.	Met acceptance criteria
Liquid Barrier:	AAMI Standard PB70 Liquid Barrier Level 3	Classified as Level 3 per AAMI Standard PB70

Note: The document states that "All tests results met acceptance criteria and were substantially equivalent to the predicate devices." While the specific numerical acceptance criteria for each test are not detailed in this summary, the general statement indicates successful compliance.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the exact sample sizes used for the performance testing.
The origin of the data is not explicitly mentioned as a country, but GRI Medical & Electronic Technology Co., Ltd. is located in ZheJiang, China. This suggests the testing may have been conducted there or by a contracted lab. The study is retrospective in the sense that it relies on laboratory testing of the device rather than a clinical trial.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable to this type of device and study. The "ground truth" for surgical drapes and equipment covers relates to objective performance criteria (e.g., barrier properties, strength, biocompatibility), which are measured in laboratory settings against established standards, not through expert consensus in a clinical diagnostic context.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods like "2+1" are typically used in studies involving human interpretation (e.g., image analysis by radiologists) to resolve discrepancies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human reader performance is being evaluated, especially with and without AI assistance. This document describes the performance testing of physical barriers (surgical drapes and equipment covers).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This information is not applicable. The device is a physical product (surgical drapes and equipment covers), not an algorithm or AI system. Therefore, the concept of "standalone performance" in the context of AI does not apply. The device itself is "standalone" in that its physical properties are tested.

7. The Type of Ground Truth Used:

The ground truth used for this device is based on objective performance standards and test methods. Specifically, the document mentions compliance with:

AAMI Standard PB70 for liquid barrier performance.
Other unnamed standards for biocompatibility (cytotoxicity, primary skin irritation, sensitization), hydrostatic pressure, impact penetration, tear strength, tensile strength, linting, and flammability.

8. The Sample Size for the Training Set:

This information is not applicable. This is not a machine learning or AI-driven device, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there is no training set for this device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for GRI, which stands for Global Reporting Initiative. The logo is in black and white and features the letters "gri" in a stylized font. There is a curved line above the "i" in the logo.

ﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴﻴ

510(k) Summary

510(k) Applicant/Owner: GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD.

1805 HongGao Road, XiuZhou Industry Zone, ZheJiang, China, 314031 86-573-83916501 86-573-83916520

Primary Contact Penny Northcutt Person for this 510(k): REGSolutions, LLC. 717 Lakeglen Drive Suwanee, GA 30024 Fax: (678) 513-0937 Phone: (678) 428-6978 Email: pennynorthcutt@theregsolutions.com

Summary Date:	November 17, 2011
Device Trade Name:	GRI Sterile and Non-Sterile Surgical Drapes andSurgical Equipment Covers
Common/Usual Name:	Surgical Drape and Drape Accessories
Device Classification:	General & Plastic SurgeryClass II - 21 CFR 878.4370
Device Product Code:	KKX Surgical DrapesMMD Surgical Equipment Covers

Device Description:

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for GRI, which is a company that provides gas research and insights. The logo is in black and white and features the letters "gri" in a stylized font. The "i" has a curved extension above it. The logo is simple and modern, and it is likely used on the company's website and marketing materials.

spunbond/polypropylene mettblown/polypropylene spunbond. Layers are thermally embossed together producing a single layer with various basis weights. Fabric is topically treated to enhance water repellency and to assure static dissipation. The drape reinforcement fabrics are constructed of various configurations of spunbond, meltblown and film. The reinforcement materials are spunbond/film laminate. The primary component of these materials is polypropylene with surfactant and blue pigment.

Predicate Device:

GRI single use drapes and surgical equipment covers are substantially equivalent to the Kimberly Clark K083234 sterile and non-sterile surgical drapes and surgical equipment covers.

Indications for Use:

GRI Drapes

Non-sterile GRI surgical drapes are sold, in bulk as single use items, to repackager/relabeler establishments for further packaging and ethylene oxide (EtO) sterilization.

GRI Surgical Equipment Covers

Non-sterile GRI surgical equipment covers are sold, in bulk as single use items, to repackager/relabeler establishments for further packaging and ethylene oxide (EtO) sterilization.

Technological Characteristics and Substantial Equivalence:

GRI single use drapes and surgical equipment covers, that is subject of this premarket notification is substantially equivalent to the predicate KC100 Surgical Drapes and Equipment Covers (K083234) in intended use statements, equivalent device construction, materials, drape design, chemical characteristics and technology performance characteristics. The performance attributes of the GRI single use drapes and surgical equipment covers are substantially equivalent to the predicate drape.

{2}------------------------------------------------

K-111458

Image /page/2/Picture/1 description: The image shows the logo for GRI, which stands for Global Reporting Initiative. The logo is in black and features the lowercase letters "gri" in a stylized font. The "i" has a curved accent mark above it, and there is a trademark symbol to the bottom right of the "i".

Summary of Testing:

GRI Surgical Drapes and Equipment Covers have met acceptance criteria for performance testing including biocompatibility (cytotoxicity, primary skin irritation testing and sensitization testing), hydrostatic pressure, impact penetration, tear strength, tensile strength, linting, and flammability. All tests results met acceptance criteria and were substantially equivalent to the predicate devices.

Conclusion:

Based on the performance testing and device attributes, it can be concluded that the GRI surgical drapes and surgical equipment covers are equivalent to the predicate devices with respect to the indications for use and technological characteristics and do not present any further safety or effectiveness questions.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular arrangement of the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" surrounding a stylized eagle-like symbol. The symbol is composed of three curved lines that resemble the wings and body of a bird.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

GRI Medical & Electronic Technology C/O Ms. Penny Northcutt President/CEO REGSolutions, LLC 717 Lakeglen Drive Suwanee, Georgia 30024

DEC - 1 2011

Re: K111458

Trade/Device Name: GRI Sterile and Non-sterile Surgical Drapes GRI Sterile and Non-sterile Surgical Equipment Covers Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: November 17, 2011 Received: November 17, 2011

Dear Ms. Northcutt:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined 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 Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{4}------------------------------------------------

Page 2 - Ms. Northcutt

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safetv/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony D. Watson

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use Form

Indications for Use

510(k) Number (if known): _ K 11458

Device Name: Surgical Drapes (Model Numbers List Attached)

GRI Sterile and Non-sterile Surgical Drapes (various models and configurations as attached)

GRI single use drapes (both sterile and non-sterile) are made of natural or synthetic material intended to be used as a protective patient covering, such as to isolate a te of surgical incision from microbial and other contamination.

Non-sterile GRI surgical drapes are sold in bulk as single use items, to repackager/ relabeler establishments for further packaging and ethylene oxide (EtO) sterilization.

The drapes are classified as level 3 per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in health-care facilities.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use × (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (OD)

Evaluation (ODE)

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K111458

{6}------------------------------------------------

|<||||458

Image /page/6/Picture/1 description: The image shows the logo for GRI, which is a company that specializes in sustainability reporting. The logo is a stylized version of the letters "gri" in a bold, sans-serif font. The "i" in the logo has a curved line above it, which gives the logo a modern and dynamic look. The logo is simple, yet effective, and it is easily recognizable.

Surgical Drapes Indications for Use Model Number List
Code(Sterile)	Code(Non-Sterile)	Description	Fabric	ProductFamily
80-01101-S	80-01101	Femoral Angiography Drape (no window)
80-01102-S	80-01102	Femoral Angiography Drape (single window)
80-01103-S	80-01103	Femoral Angiography Drape (dual windows)
80-01104-S	80-01104	Femoral Angiography Drape
80-01105-S	80-01105	Femoral Angiography Drape (dual windows) Tri laminate material, Extra Long
80-01106-S	80-01106	Femoral Angiography Drape (dual windows) Extra-long	50gsm SMS	Angiography
80-01107-S	80-01107	Femoral Angiography Drape (single window) with Trough
80-01108-S	80-01108	Femoral Angiography Drape (dual windows) Tri laminate Material with Side Panel
80-01109-S	80-01109	Femoral Angiography Drape (no window) Extra-long
80-01110-S	80-01110	Femoral Angiography Drape (single window) Extra-long
80-01201-S	80-01201	Femoral Angiography Drape (no window)
80-01202-S	80-01202	Femoral Angiography Drape (single window)
80-01203-S	80-01203	Femoral Angiography Drape (dual windows)
80-01204-S	80-01204	Femoral Angiography Drape
80-01205-S	80-01205	Femoral Angiography Drape (dual windows) Tri laminate material, Extra Long
80-01206-S	80-01206	Femoral Angiography Drape (dual windows) Extra-long	35gsm SMS
80-01207-S	80-01207	Femoral Angiography Drape (single window) with Trough
80-01208-S	80-01208	Femoral Angiography Drape (dual windows) Tri laminate Material with Side Panel
80-01209-S	80-01209	Femoral Angiography Drape (no window) Extra-long
80-01210-S	80-01210	Femoral Angiography Drape (single window) Extra-long
80-02101-S	80-02101	Bilateral Under Leg/Perineal Drape		Cardiovascular
80-02102-S	80-02102	CV Slip Drape
80-02103-S	80-02103	Cardiovascular Incise W/Armboard cover	50gsm SMS
80-02104-S	80-02104	Cardiovascular Universal set
80-02105-S	80-02105	Clearview Split Drape
80-02203-S	80-02203	Cardiovascular Incise W/Armboard cover	35gsm SMS
80-02204-S	80-02204	Cardiovascular Universal set
80-02205-S	80-02205	Clearview Split Drape
80-03101-S	80-03101	Cystoscopy Drape	50gsm SMS	Cystoscopy
80-03102-S	80-03102	Cystoscopy T Drape
80-03201-S	80-03201	Cystoscopy Drape	35gsm SMS
80-03202-S	80-03202	Cystoscopy T Drape
80-04101-S	80-04101	Fenestrated EENT Drape		EENT Drape
80-04104-S	80-04104	Head Drape
80-04105-S	80-04105	Head Drape with Detachable Turban	50gsm SMS
80-08102-S	80-08102	Eye Drape W/Fluid Pouch
80-08103-S	80-08103	Basic ophthalmic Drape
80-08104-S	80-08104	Ophthalmic Drape
80-04201-S	80-04201	Fenestrated EENT Drape
80-04204-S	80-04204	Head Drape
80-04205-S	80-04205	Head Drape with Detachable Turban	35gsm SMS
80-08202-S	80-08202	Eye Drape W/Fluid Pouch
80-08203-S	80-08203	Basic ophthalmic Drape
80-08204-S	80-08204	Ophthalmic Drape
80-05101-S	80-05101	Side Drape 29.5x39 in		GeneralSurgery
80-05102-S	80-05102	Bottom Drape 69x71 in
80-05104-S	80-05104	Top Drape 59x94.5 in
80-05107-S	80-05107	U-Drape
80-05109-S	80-05109	Bottom drape 72x75 in double cord holders
80-05110-S	80-05110	Top drape 50x108 in double cord holders
80-05111-S	80-05111	Breast Chest U Drape
80-05112-S	80-05112	Breast Drape	50gsm SMS
80-05113-S	80-05113	Bar Drape 96x44 in w/ Arm Board Covers
80-05114-S	80-05114	Bar Drape 106x62 in w/ Arm Board Covers
80-05115-S	80-05115	Ortho Bar Drape
80-05116-S	80-05116	Laparotomy Drape 100x124 in
80-05117-S	80-05117	Laparotomy 104x120 in
80-05118-S	80-05118	Transverse Laparotomy Drape
80-05119-S	80-05119	Pediatric Laparotomy Drape
80-05120-S	80-05120	Thyroid Drape

80-05122-S	80-05122	Chest Drape
80-05123-S	80-05123	Laparoscopic Drape
80-05125-S	80-05125	Laparoscopic Colecystectomy Drape
80-05128-S	80-05128	Side drape 38.5x77 in
80-05129-S	80-05129	Side Drape 90x90 in
80-05201-S	80-05201	Side Drape 29.5x39 in
80-05202-S	80-05202	Bottom Drape 69x71 in
80-05204-S	80-05204	Top Drape 59x94.5 in
80-05207-S	80-05207	U-Drape
80-05209-S	80-05209	Bottom drape 72x75 in double cordholders
80-05210-S	80-05210	Top drape 50x108 in double cordholders
80-05211-S	80-05211	Breast Chest U Drape
80-05212-S	80-05212	Breast Drape
80-05213-S	80-05213	Bar Drape 96x44 in w/ Arm BoardCovers
80-05214-S	80-05214	Bar Drape 106x62 in w/ Arm BoardCovers	35gsmSMS
80-05215-S	80-05215	Ortho Bar Drape ·
80-05216-S	80-05216	Laparotomy Drape 100x124 in
80-05217-S	80-05217	Laparotomy 104x120 in
80-05218-S	80-05218	Transverse Laparotomy Drape
80-05219-S	80-05219	Pediatric Laparotomy Drape
80-05220-S	80-05220	Thyroid Drape
80-05222-S	80-05222	Chest Drape
80-05223-S	80-05223	Laparoscopic Drape
80-05225-S	80-05225	Laparoscopic Colecystectomy Drape
80-05228-S	80-05228	Side drape 38.5x77 in
80-05229-S	80-05229	Side Drape 90x90 in
80-07101-S	80-07101	C-Section Fluid Collection DrapeFenestrated Incise
80-07102-S	80-07102	C-Section Drape with FenestratedIncise	50gsmSMS	Obstetrics
80-07103-S	80-07103	C-Section Drape with full Incise
80-07104-S	80-07104	C-Section Fluid Collection Drape fullIncise
80-07201-S	80-07201	C-Section Fluid Collection DrapeFenestrated Incise
80-07202-S	80-07202	C-Section Drape with FenestratedIncise	35gsmSMS
80-07203-S	80-07203	C-Section Drape with full Incise
80-07204-S	80-07204	C-Section Fluid Collection Drape fullIncise
80-09101-S	80-09101	Lower Extremity Drape	50gsm	Orthopedics
80-09104-S	80-09104	Hip Drape W/Pockets
80-09105-S	80-09105	Body Split Drape
80-09106-S	80-09106	Split Drape
80-09107-S	80-09107	U-Drape
80-09108-S	80-09108	Hand Drape
80-09109-S	80-09109	Shoulder Arthroscopy Drape
80-09110-S	80-09110	Shoulder Split Drape
80-09111-S	80-09111	Beach Chair Shoulder
80-09201-S	80-09201	Lower Extremity Drape
80-09202-S	80-09202	Knee Arthroscopy Drape
80-09204-S	80-09204	Hip Drape W/Pockets
80-09205-S	80-09205	Body Split Drape	35gsm
80-09207-S	80-09207	U-Drape	SMS
80-09208-S	80-09208	Hand Drape
80-09209-S	80-09209	Shoulder Arthroscopy Drape
80-09210-S	80-09210	Shoulder Split Drape
80-11101-S	80-11101	Lithotomy Drape
80-11102-S	80-11102	Lithotomy T-Drape	50gsm
80-11105-S	80-11105	Leggings Drape 54x31 in	SMS
80-11201-S	80-11201	Lithotomy Drape		Peri-GYN
80-11202-S	80-11202	Lithotomy T-Drape	35gsm
80-11205-S	80-11205	Leggings Drape 54x31 in	SMS
80-12101-S	80-12101	Half Drape
80-12102-S	80-12102	Medium Drape	50gsm
80-12103-S	80-12103	Large Drape	SMS
80-12104-S	80-12104	XL Drape
80-12201-S	80-12201	Half Drape		Ancillary
80-12202-S	80-12202	Medium Drape	35gsm
80-12203-S	80-12203	Large Drape	SMS
80-12204-S	80-12204	XL Drape
85-07341-S	85-07341	7"with pull tab Stockinette Drape
85-09481-S	85-09481	9" with pull tab Stockinette Drape
85-12481-S	85-12481	12" with pull tab Stockinette Drape
85-16481-S	85-16481	16" with pull tab Stockinette Drape	Polyesterknitstockinette	StockinetteDrape
85-07340-S	85-07340	7" without pull tab Stockinette Drape
85-09480-S	85-09480	9" without pull tab Stockinette Drape
85-12480-S	85-12480	12" without pull tab Stockinette Drape
85-16480-S	85-16480	16" without pull tab Stockinette Drape

፡

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows the logo for GRI, which stands for Global Reporting Initiative. The logo is in black and white and features the lowercase letters "gri" in a stylized font. There is a curved line above the "i" that resembles a crescent moon. The letters are connected and have a modern, sleek appearance.

{8}------------------------------------------------

KII1458

Image /page/8/Picture/1 description: The image shows the logo for GRI, which is written in a stylized lowercase font. The letters 'g', 'r', and 'i' are connected and written in black. The 'i' has a curved line above it, resembling a crescent moon. The letters are slightly slanted to the right.

{9}------------------------------------------------

K111458

Image /page/9/Picture/1 description: The image shows the logo for GRI, which is a company that specializes in sustainability reporting. The logo is a stylized version of the letters "gri" in a sans-serif font. The letters are black, and the "i" has a curved top. The logo is simple and modern.

Key for Surgical Drape Codes:

80=Surgical drape set

Prefix

80=Surgical drape series

Suffix - 1&2

First two positions represent product category
01 Angiography
02 Cardiovascular
03 Cystoscopy
04 EENT

{10}------------------------------------------------

05 General Surgery
07 Obstetrics
09 Orthopedic
11 Peri-GYN
12 Ancillary
14 Accessories
Suffix 3
Third position represents "fabric" 1 = SMS - 50gsm
2 = SMS 35gsm
Suffix -- 4&5
Fourth and Fifth positions represent Product identification in sequential order of development Sixth position represents "packaging"
. Suffix 6
S = Sterile

{11}------------------------------------------------

Image /page/11/Picture/1 description: The image shows the logo for GRI, which is a company that specializes in sustainability reporting. The logo is in black and white and features the letters "gri" in a stylized font. The "i" in the logo has a curved line above it, which gives the logo a unique look. The logo is simple and modern, and it is easily recognizable.

Indications for Use Form

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Surgical Equipment Covers (Model Numbers List Attached)

GRI Sterile and Non-sterile Surgical Equipment Covers (various models and configurations as attached)

Non-sterile GRI surgical equipment covers are sold in bulk as single use items, to repackager/ relabeler establishments for further packaging and ethylene oxide (EtO) sterilization.

The covers are classified as level 3 per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in health-care facilities.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use × (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K/11458

{12}------------------------------------------------

Image /page/12/Picture/1 description: The image shows the logo for GRI, which is a company that specializes in sustainability reporting. The logo is a stylized lowercase "gri" in black. There is a curved line above the "i" that resembles a check mark.

Surgical Equipment Covers	Model Number	Indications for Use	List
80-13101-S	80-13101	Back Table Cover 44x75in
80-13102-S	80-13102	Back Table Cover 44x90in
80-13103-S	80-13103	Back Table Cover 50x90in
80-13104-S	80-13104	Back Table Cover 80x90in	43gsm	Back TableCovers
80-13107-S	80-13107	Back Table Cover 55x75in	SMS
80-13108-S	80-13108	Back Table Cover 60x75in
80-13109-S	80-13109	Back Table Cover 60x90in
80-13110-S	80-13110	Back Table Cover 44x44in
80-13105-S	80-13105	Mayo Stand Cover 23x54in	43gsm	Mayo StandCovers
80-13106-S	80-13106	Mayo Stand Cover 29.5x57in	SMS
80-14101-S	80-14101	Underbuttocks Drape w/Pouch
80-14102-S	80-14102	Underbuttocks Drape 48x36in	50gsm	Accessories
80-14103-S	80-14103	Drape Underbuttocks W/Pouch	SMS
80-14104-S	80-14104	Underbuttocks Drape 38x44in

Key for Surgical Drape Codes:

80=Surgical drape series

Suffix - 1&2

Prefix

bo-Surgical drape series

First two positions represent product category

01 Angiography
02 Cardiovascular
03 Cystoscopy
04 EENT
05 General Surgery
07 Obstetrics
09 Orthopedic
11 Peri-GYN
12 Ancillary
14 Accessories

Suffix - 3

1 = SMS 50gsm
2 = SMS 35gsm
Suffix 4&5 Fourth and Fifth positions represent Product

Suffix — 6

identification in sequential order of development Sixth position represents "packaging"
Third position represents "fabric"
S = Sterile

Regulation Number and Section

§ 878.4370 Surgical drape and drape accessories.

(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.