GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS
Device Facts
| Record ID | K111458 |
|---|---|
| Device Name | GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS |
| Applicant | Gri Medical & Electronic Technology Co., Ltd. |
| Product Code | KKX · General, Plastic Surgery |
| Decision Date | Dec 1, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4370 |
| Device Class | Class 2 |
Indications for Use
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 Story
Single-use surgical drapes and equipment covers; constructed from three-layer polypropylene laminate (spunbond/meltblown/spunbond) or polyester knit stockinette; thermally embossed; topically treated for water repellency and static dissipation. Provided in various sizes/shapes; may include fluid collection pouches or clear film panels. Used in clinical settings to isolate surgical sites or cover equipment. Non-sterile versions sold in bulk for repackaging and EtO sterilization. Acts as a physical barrier to microbial and fluid contamination. Benefits patient by reducing risk of surgical site infection.
Clinical Evidence
Bench testing only. Performance testing included biocompatibility (cytotoxicity, primary skin irritation, sensitization), hydrostatic pressure, impact penetration, tear strength, tensile strength, linting, and flammability. All results met acceptance criteria.
Technological Characteristics
Materials: Polypropylene (SMS laminate) and polyester knit. Barrier performance: AAMI Level 3 per PB70. Construction: Thermally embossed layers, topically treated for water repellency and static dissipation. Form factor: Various sizes/shapes including fenestrated, split, and equipment-specific covers. Sterilization: Ethylene oxide (EtO) for sterile versions.
Indications for Use
Indicated for use as protective patient coverings to isolate surgical incision sites from contamination and as protective barrier covers for surgical equipment in healthcare facilities.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Kimberly Clark K083234
Submission Summary (Full Text)
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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.
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## 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 and<br>Surgical Equipment Covers | | |
| Common/Usual Name: | Surgical Drape and Drape Accessories | | |
| Device Classification: | General & Plastic Surgery<br>Class II - 21 CFR 878.4370 | | |
| Device Product Code: | KKX Surgical Drapes<br>MMD Surgical Equipment Covers | | |
#### 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 .
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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
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 Surgical Equipment Covers
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.
#### 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.
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## 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.
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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.
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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
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## 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
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# |<||||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<br>(Sterile) | Code<br>(Non-Sterile) | Description | Fabric | Product<br>Family |
| 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 | | General<br>Surgery |
| 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 cord<br>holders | | |
| 80-05210-S | 80-05210 | Top drape 50x108 in double cord<br>holders | | |
| 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 Board<br>Covers | | |
| 80-05214-S | 80-05214 | Bar Drape 106x62 in w/ Arm Board<br>Covers | 35gsm<br>SMS | |
| 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 Drape<br>Fenestrated Incise | | |
| 80-07102-S | 80-07102 | C-Section Drape with Fenestrated<br>Incise | 50gsm<br>SMS | Obstetrics |
| 80-07103-S | 80-07103 | C-Section Drape with full Incise | | |
| 80-07104-S | 80-07104 | C-Section Fluid Collection Drape full<br>Incise | | |
| 80-07201-S | 80-07201 | C-Section Fluid Collection Drape<br>Fenestrated Incise | | |
| 80-07202-S | 80-07202 | C-Section Drape with Fenestrated<br>Incise | 35gsm<br>SMS | |
| 80-07203-S | 80-07203 | C-Section Drape with full Incise | | |
| 80-07204-S | 80-07204 | C-Section Fluid Collection Drape full<br>Incise | | |
| 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"<br>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 | Polyester<br>knit<br>stockinette | Stockinette<br>Drape |
| 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 | | |
፡
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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.
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# 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.
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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
-
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- 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
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## 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)
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.
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
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| 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 Table<br>Covers |
| 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 Stand<br>Covers |
| 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
