3M STERI-DRAPE FABRIC SURGICAL DRAPES
Device Facts
| Record ID | K140330 |
|---|---|
| Device Name | 3M STERI-DRAPE FABRIC SURGICAL DRAPES |
| Applicant | 3M Healthcare |
| Product Code | KKX · General, Plastic Surgery |
| Decision Date | Aug 18, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4370 |
| Device Class | Class 2 |
Indications for Use
3M Steri-Drape Fabric Surgical Drapes are used to create a sterile field for surgical procedures. They are provided sterile and intended for external use only. 3M Steri-Drape non-sterile fabric drapes are provided to other manufacturers for further processing using ethylene oxide. 3M provides information on compatibility with ethylene oxide (EtO) processing. Non-sterile surgical drapes are sold to repackager or relabeler establishments for EtO sterilization according to ISO 11135-1:2007. Sterile surgical drapes are sold directly to end users after EtO sterilization validation to ISO 11135-1:2007.
Device Story
3M Steri-Drape Fabric Surgical Drapes are single-use, disposable, dual-layer drapes designed to create a sterile field during surgical procedures. The device consists of an absorbent nonwoven fabric thermally bonded to a protective barrier film, providing an AAMI Level 4 liquid barrier to prevent fluid strike-through and microbial penetration. Drapes are provided in various sizes and configurations (with or without apertures, incise areas, or pouches) to accommodate specific clinical needs. The device is placed over the patient by the surgical team to delineate the surgical site. By acting as a physical barrier, the drapes protect the patient and the surgical site from contamination. The drapes are supplied either sterile to end-users or non-sterile to kit manufacturers for subsequent ethylene oxide sterilization.
Clinical Evidence
Bench testing only. Performance evaluated against ANSI/AAMI PB70:2012, ASTM F1670-08, ISO 9073-3:1989, ISO 13938-1:1999, ISO 9073-10:2003, 16 CFR Part 1610, ISO 10993-5:2009, and ISO 10993-10:2010. Results confirmed AAMI Level 4 barrier performance, non-cytotoxicity, non-irritation, and non-sensitization, with physical properties (tensile/burst strength) comparable to the predicate.
Technological Characteristics
Dual-layer construction: nonwoven fabric (polylactide/polypropylene resin) thermally bonded to a barrier film (EMA copolymers, hydrocarbon resin, LDPE, LLDPE). AAMI Level 4 liquid barrier. Single-use. Sterilization via ethylene oxide. Various dimensions and configurations. Complies with ANSI/AAMI PB70:2012, ASTM F1670-08, and ISO 10993 standards.
Indications for Use
Indicated for creating a sterile field during surgical procedures. Intended for external use only. Applicable to patients undergoing surgical procedures requiring a sterile barrier.
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
- 3M Steri-Drape Surgical Fabric Drapes (K031287)
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 18, 2014
3M Health Care Mr. Mark Burville Regulatory Affairs Manager 3M Center, 2510 Conway Ave., Building 275-5W-06 St Paul, MN 55144
Re: K140330 Trade/Device Name: 3 M Steri-Drape Fabric Surgical Drapes Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: Class II Product Code: KKX Dated: July 14, 2014 Received: July 16, 2014
Dear Mr. Burville,
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. Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.
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
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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 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 and Part 809), please contact 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/Safety/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mary S. Runner -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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#### Indications for Use
510(k) Number (if known) K140330
Device Name 3M Steri-Drape Fabric Surgical Drapes
Indications for Use (Describe)
3M Steri-Drape Fabric Surgical Drapes are used to create a sterile field for surgical procedures. They are provided sterile and intended for external use only.
3M Steri-Drape non-sterile fabric drapes are provided to other manufacturers for further processing using ethylene oxide. 3M provides information on compatibility with ethylene oxide processing.
Non-sterile surgical drapes are sold to repackager or relabeler establishments for EtO sterilization according to ISO 11135-1:2007. Sterile surgical drapes are sold directly to end users after EtO sterilization validation to ISO 11135-1:2007.
Type of Use (Select one or both, as applicable)
] Prescription Use (Part 21 CFR 801 Subpart D)
[X] Over-The-Counter Use (21 CFR 801 Subpart C)
#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
#### FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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| Catalog Number(s) | Dimensions | Name/Descriptor |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| 1031 | 228cm · 90in (Width Top)<br>182cm · 72in (Width Bottom)<br>285cm · 112in (Length) | Laparoscopic Drape/Supine Position |
| 1032 | 228cm · 90in (Width Top)<br>117cm · 46in (Length of<br>Panel)<br>241cm · 95in (Length) | Laparoscopic Drape/Lithotomy<br>Position |
| 1034 | 152cm x 200cm<br>60in x 78in | Central Venous Catheter Drape |
| 1078 | 196cm x 200cm<br>No inches stated | Perineal Drape with Pouch |
| 1079 | 195cm · 77in (Width Top)<br>117cm · 46in (Length of<br>Panel)<br>179cm · 70in (Length) | Gynecologic Drape |
| 1080 | 195cm · 77in (Width Top)<br>117cm · 46in (Length of<br>Panel)<br>179cm · 70in (Length) | Gynecologic Drape |
| 1081 | 152cm x164cm Upper<br>60in x 64in<br>117cm / 46in Lower | TUR/Urological Drape |
| 1082 | 235cm · 92in<br>300cm · 118 in | Abdominal Vaginal Drape |
| 1084 | 86cm x108cm<br>34in x 42in | Under Buttocks Drape with Pouch |
| 1089 | 57cm x 66cm<br>22in x 26in | Utility Sheet (2) |
| 1090 | 182cm x 228cm<br>72in x 90in | Femoral Angiography Drape |
| 1092 | 57cm x 66cm<br>22in x 25in | Small Drape with Adhesive Aperture |
| 1094 | 226cm x 320cm<br>90in x 126in | Arthroscopy Sheet with Pouch |
| 1135 | 279cm x 183cm<br>110in x 72in<br>15cm x 13cm<br>5.9in x 5 in | Peripherally Inserted Central Catheter<br>Drape |
| *1190NS | 228cm x 330cm<br>89in x 130in | Femoral Angiography Drape |
| 1191 | 229cm x 330cm<br>90in x 130in | Femoral Angiography Drape |
| Catalog Number(s) | Dimensions | Name/Descriptor |
| 1192 | 152cm x 170cm<br>60in x 67in | Venous/Arterial Access Drape |
| 1193 | 290cm x 345cm<br>114in x 136in | Angiography Drape |
| 1194 | 292cm · 115in (Width Top)<br>228cm · 89in (Width Bottom)<br>304cm · 120in (Length) | Arthroscopy Sheet with Pouch |
| 2065 | 195cm · 77in (Width Top)<br>271cm · 106in (Total Length) | Abdominoperineal Incise Drape |
| 7964 | 254cm x 279cm<br>100in x 110in | Abdominoperineal Incise Drape-<br>Lithotomy Position |
| 7965 | 254cm · 100in (Width Top)<br>195cm · 76in (Width Bottom)<br>308cm · 121in (Length) | Cesarean Section Incise Sheet with<br>Pouch |
| 7966 | 254cm · 100in (Width Top)<br>195cm · 76in (Width Bottom)<br>310cm · 122in (Length) | Cesarean Section Sheet with Aperture<br>Pouch |
| 9023 | 76cm x 170cm<br>29in x 67in | Perineal Aperture Drape |
| 9026 | 6cm x 8cm (Aperture)<br>2.3in x 3.1in<br>55cm x 55cm<br>21in x 21in | Aperture Drape |
| 9027 | Part 1 50cm x 75cm<br>19in x 19in<br>Part 2 50cm x 75cm<br>19in x 19in | Adjustable Aperture Drape |
| 9027L | Part 1 75cm x 100cm<br>29in x 39in<br>Part 2 75cm x 100cm<br>29in x 39in | Adjustable Adhesive Aperture Drape |
| 9028 | 6cm x 8cm (Aperture)<br>2.3 in x 3.1 in<br>75cm x 75cm<br>29in x 29in | Adhesive Aperture Drape |
| 9029 | 15 cm x 6 cm (Aperture)<br>6 in x 2 in<br>75cm x 75cm<br>29in x 29in | Adhesive Aperture Drape |
| 9030 | 6cm x 8cm (Aperture)<br>2 in x 3in<br>152cm x 120cm<br>60in x 47in | Adhesive Aperture Drape |
| Catalog Number(s) | Dimensions | Name/Descriptor |
| 9031 | 8cm x 6cm (Aperture) | Adhesive Aperture Drape |
| | 3 in x 2 in | |
| | 150cm x 183cm | |
| | 59in x 72in | |
| *9033NS | 150cm x 183cm | Triangular Aperture Drape |
| | 59in x 72in | |
| 9040 | 75cm x 114cm | Leggings (2) |
| | 29in x 44in | |
| 9040L (pair) | 85cm x 130cm | Legging Long |
| | 33in x 51in | |
| 9041 | 35cm x 60cm | Extremity Cover (S) |
| | 13.5in x 23.5in | |
| 9042 | 35cm x 100cm | Extremity Cover (L) |
| | 13.5in x 39in | |
| 9043 | 7 cm x 70 cm (split) | Adhesive Split Sheet |
| | 2.5in x 25 in | |
| | 152cm x 183cm | |
| | 60in x 72in | |
| 9044 | 7cm x 70cm (split) | Adhesive Split Sheet |
| | 2.5in x 25 in | |
| | 152cm x 250cm | |
| | 60in x 98in | |
| 9045 | 20cm x 100cm (split) | Adhesive Split Sheet |
| | 7in x 39 in | |
| | 228cm x 260cm | |
| | 89.5in x 102in | |
| 9045R | 20cm x 100cm (split) | Reinforced Adhesive Split Sheet |
| | 7in x 39 in | |
| | 228cm x 260cm | |
| | 89.5in x 102in | |
| 9046 | 183cm x 200cm | Bilateral Adhesive Split Sheet |
| | 72in x 78in | |
| 9046L | 228cm x 260cm | Bilateral Adhesive Split Sheet |
| | 89in x 102in | |
| 9047 | 183cm x 152cm | Neuro Split Sheet with Pouch |
| | 72in x 60in | |
| 9048 | 20cm x 40cm (split) | Adhesive Split Sheet |
| | 7in x 15 in | |
| | 228cm x 260cm | |
| | 90in x 102in | |
| 9050 | 12cm x 18cm (aperture) | Adhesive Aperture Drape |
| | 4.5in x 8in | |
| | 228cm x 300cm | |
| | 90in x 138in | |
| Catalog Number(s) | Dimensions | Name/Descriptor |
| 9051 | 183cm x 315cm<br>72in x 124in | Thyroid Drape |
| 9052 | 355cm x 293cm<br>140in x 115in | Hand Drape |
| 9053 | 228cm x 300cm<br>89in x 118in | Extremity Drape |
| 9054 | 195cm x 300cm<br>77in x 118in | Hand and Foot Drape |
| 9055 | 300cm · 118in (Width Top)<br>228cm · 90in (Width Bottom)<br>353cm · 139in (Length) | Hip Drape with Pouches |
| 9056 | 195cm x 300cm<br>77in x 118in | Bilateral Foot Drape |
| 9057 | 292cm · 115in (Width Top)<br>228cm · 89in (Width Bottom)<br>305cm · 120in (Length) | Extremity Drape with Anesthesia<br>Screen |
| 9058 | 228cm x 300cm<br>90in x 118in | Bilateral Knee Drape |
| 9062 | 254cm · 100in (Width Top)<br>183cm · 72in (Width Bottom)<br>285cm · 112in (Length) | Laparotomy Drape-Transverse |
| 9063 | 254cm · 100in (Width Top)<br>183cm · 72in (Width Bottom)<br>285cm · 112in (Length) | Laparotomy Drape |
| 9066 | 85cm x 85cm<br>33in x 33in | Under Buttock Drape with Cuff |
| 9067 | 45cm x 37cm<br>17.75in x 14.5in | Drape Sheet |
| 9069 | 90cm x 75cm<br>36in x 30in | Drape Sheet |
| 9070 | 114cm x 87cm<br>45in x 34in | Turban Drape Sheet |
| 9071 | 97cm x 97cm<br>38 in x 38in | Drape Sheet |
| 9072 | 114cm x 150cm<br>44in x 59in | Drape Sheet |
| 9074 | 150cm x 150cm<br>60in x 60in | Instrument Table Cover/Drape Sheet |
| 9077 | 200cm x 250cm<br>78in x 59in | Drape Sheet |
| 9077R | 150cm x 200cm<br>No inches stated | Instrument Table Cover Reinforced |
| 9079 | 200cm x 228cm<br>78in x 90in | Drape Sheet |
| Catalog Number(s) | Dimensions | Name/Descriptor |
| 9083 | 55cm x 55cm<br>19.75in x 19.75in | Adhesive Towel Drape |
| 9084 | 75cm x 75cm<br>29in x 29in | Adhesive Towel Drape |
| 9085 | 100cm x 85cm<br>39in x 33in | Adhesive Towel Drape |
| 9085W | 97cm x 115cm<br>38in x 45in | Adhesive Towel Drape |
| 9086 | 100cm x75cm<br>39in x 29in | Adhesive Towel Drape |
| 9087 | 183cm x 183cm<br>72in x 72in | Adhesive Drape Sheet |
| 9088 | 200cm x 250cm<br>78in x 59in | Adhesive Drape Sheet |
| 9089 | 170cm x 170cm<br>67in x 67in | Adhesive Drape Sheet |
| 9090 | 300cm x 228cm<br>118in x 90in | Adhesive Drape Sheet |
| 9196 | 16cm x 95cm (Split)<br>6in x 37in<br>228cm x 260cm<br>90in x 102in | Shoulder Split Sheet with Pouch |
| Catalog Number(s) | Dimensions | Name/Descriptor |
| 1031 | 27cm x 30cm<br>10.5in x 11.5in (Aperture)<br>228cm · 90in (Width Top)<br>182cm · 72in (Width Bottom)<br>285cm · 112in (Length) | Laparoscopic Drape/Supine Position |
| 1032 | 27cm x 30cm<br>10.5in x 11.5in (Aperture 1)<br>12cm x 15.5cm<br>4.5in x 6cm (Aperture 2)<br>228cm · 90in (Width Top)<br>117cm · 46in (Length of Panel)<br>241cm · 95in (Length) | Laparoscopic Drape/Lithotomy<br>Position |
| 1034 | 34.5cm x 34.5cm (13.5in x 13.5in)<br>Film with 10cm (4 in) Circle Aperture<br>152cm x 200cm<br>60in x 78in | Central Venous Catheter Drape |
| 1078 | 9cm x 12cm<br>3.3in x 4.5in (Aperture)<br>196cm x 200cm<br>77in x 78in | Perineal Drape with Pouch |
| 1079 | 9cm x 12cm<br>3.3in x 4.5in (Aperture)<br>195cm · 77in (Width Top)<br>117cm · 46in (Length of Panel)<br>179cm · 70in (Length) | Gynecologic Drape |
| 1080 | 9cm x 12cm<br>3.3in x 4.5in (Aperture)<br>195cm · 77in (Width Top)<br>117cm · 46in (Length of Panel)<br>179cm · 70in (Length) | Gynecologic Drape |
| 1081 | 20cm x 10cm (7.8in x 3.9in)<br>Film with 6cm<br>(2 in) Circle Aperture<br>152cm x164cm (60in x 64in)<br>117cm · 46in (Length of Panel) | TUR/Urological Drape |
| Catalog Number(s) | Dimensions | Name/Descriptor |
| 1082 | 23cm x 28cm | Abdominal Vaginal Drape |
| | 9in x 11in (Aperture) | |
| | 235cm · 92 in (Width) | |
| | 300cm · 118 in (Length) | |
| 1084 | 86cm x 63cm | Under Buttocks Drape with Pouch |
| | 34in x 24.5in (Pouch) | |
| | 86cm x45cm | |
| | 34in x 17.5in | |
| 1089 | 57cm x 66cm | Utility Sheet (2) |
| | 22in x 26in | |
| 1090 | 6.4cm x 8.9cm | Femoral Angiography Drape |
| | 2.5in x 3.5in (Aperture) | |
| | 182cm x 228cm | |
| | 72in x 90in | |
| 1092 | 6cm · 2.25in (Circle | Small Drape with Adhesive Aperture |
| | Aperture) | |
| | 57cm x 66cm | |
| | 22in x 25in | |
| 1094 | 23cm x 28cm (9in x 11in) Film | Arthroscopy Sheet with Pouch |
| | with 6cm (2.25in) Circle | |
| | Aperture | |
| | 226cm x 320cm | |
| | 90in x 126in | |
| 1135 | 28cm x 26cm (11in x 10in) | Peripherally Inserted Central Catheter |
| | Film with 15cm x 13cm (5.9in | Drape |
| | x 5in) Aperture | |
| | 183cm x 279cm | |
| | 72in x 110in | |
| *1190NS | 10cm x 7.5cm | Femoral Angiography Drape |
| | 4in x 3in (Aperture) | |
| | 91cm x 330cm | |
| | 35in x 130in | |
| | 228cm x 330cm | |
| | 89in x 130in | |
| 1191 | 11cm x 14cm | Femoral Angiography Drape |
| | 4in x 5.5in (Aperture) | |
| | 91cm x 228cm | |
| | 35in x 89in | |
| | 229cm x 330cm | |
| | 90in x 130in | |
| 1192 | 8cm x 20cm | Venous/Arterial Access Drape |
| | 3in x 7.5in (Aperture) | |
| | 152cm x 170cm | |
| | 60in x 67in | |
| Catalog Number(s) | Dimensions | Name/Descriptor |
| 1193 | 7.5cm x 10cm<br>3in x 4in (Aperture)<br>154cm x 154cm<br>60in x 60in<br>290cm x 345cm<br>114in x 136in | Angiography Drape |
| 1194 | 23cm x 28cm (9in x 11in) Film<br>with 6cm (2.25in) Circle<br>Aperture<br>292cm · 115in (Width Top)<br>228cm · 89in (Width Bottom)<br>304cm · 120in (Length) | Arthroscopy Sheet with Pouch |
| 2065 | 41cm x 45cm<br>(16in x 17in) Incise<br>12cm x 15.5cm<br>(4.75in x 6in) Aperture<br>195cm · 77in<br>271cm · 106in<br>117cm · 46in (Length of Panel) | Abdominoperineal Incise Drape |
| 7964 | 30cm x 30cm<br>12in x 12in (Incise)<br>254cm x 279cm<br>100in x 110in | Abdominoperineal Incise Drape-<br>Lithotomy Position |
| 7965 | 30cm x 30cm<br>12in x 12in (Incise)<br>254cm · 100in (Width Top)<br>195cm · 76in (Width Bottom)<br>308cm · 121in (Length) | Cesarean Section Incise Sheet with<br>Pouch |
| 7966 | 30cm x 30cm<br>12in x 12in (Incise) with 20cm<br>x 24 cm (8in x 9.5in) Aperture<br>254cm · 100in (Width Top)<br>195cm · 76in (Width Bottom)<br>310cm · 122in (Length) | Cesarean Section Sheet with Aperture<br>Pouch |
| 9023 | 6cm x 8cm<br>2.3in x 3.1in (Aperture)<br>76cm x 170cm<br>29in x 67in | Perineal Aperture Drape |
| 9026 | 6cm x 8cm<br>2.3in x 3.1in (Aperture)<br>55cm x 55cm<br>21in x 21in | Aperture Drape |
| Catalog Number(s) | Dimensions | Name/Descriptor |
| 9027 | 11cm x 12.5cm<br>4in x 5in (Aperture)<br>Part 1 50cm x 75cm 19in x 29in<br>Part 2 50cm x 75cm 19in x 29in | Adjustable Aperture Drape |
| 9027L | 11cm x 12.5cm<br>4in x 5in (Aperture)<br>Part 1 75cm x 100cm<br>29in x 39in<br>Part 2 75cm x 100cm<br>29in x 39in | Adjustable Adhesive Aperture Drape |
| 9028 | 6cm x 8cm<br>2.3in x 3.1in (Aperture)<br>75cm x 75cm<br>29in x 29in | Adhesive Aperture Drape |
| 9029 | 15 cm x 6 cm<br>6in x 2in (Aperture)<br>75cm x 75cm<br>29in x 29in | Adhesive Aperture Drape |
| 9030 | 6cm x 8cm<br>2in x 3in (Aperture)<br>152cm x 120cm<br>60in x 47in | Adhesive Aperture Drape |
| 9031 | 8cm x 6cm<br>3in x 2in (Aperture)<br>150cm x 183cm<br>59in x 72in | Adhesive Aperture Drape |
| *9033NS | 12cm x 11cm<br>4.5in x 4in (Aperture)<br>150cm x 183cm<br>59in x 72in | Triangular Aperture Drape |
| 9040 | 75cm x 114cm (includes foldover)<br>29in x 44in | Leggings (2) |
| 9040L (pair) | 85cm x 130cm (includes foldover)<br>33in x 51in | Legging Long |
| 9041 | 35cm x 60cm (includes foldover)<br>13.5in x 23.5in | Extremity Cover (S) |
| 9042 | 35cm x 100cm (includes foldover)<br>13.5in x 39in | Extremity Cover (L) |
| Catalog Number(s) | Dimensions | Name/Descriptor |
| 9043 | 7cm x 70cm<br>2.5in x 25in (Split)<br>152cm x 183cm<br>60in x 72in | Adhesive Split Sheet |
| 9044 | 7cm x 70cm<br>2.5in x 25in (Split)<br>152cm x 250cm<br>60in x 98in | Adhesive Split Sheet |
| 9045 | 20cm x 100cm<br>7in x 39 in (Split)<br>228cm x 260cm<br>89.5in x 102in | Adhesive Split Sheet |
| 9045R | 20cm x 100cm<br>7in x 39 in (Split)<br>228cm x 260cm<br>89.5in x 102in | Reinforced Adhesive Split Sheet |
| 9046 | 15cm x 50 cm<br>6in x 19in (Split)<br>183cm x 200cm<br>72in x 78in | Bilateral Adhesive Split Sheet |
| 9046L | 44cm x 100cm<br>17in x 39in (Split)<br>228cm x 260cm<br>90in x 102in | Bilateral Adhesive Split Sheet |
| 9047 | 16cm x 40cm<br>6in x 15in (Split)<br>183cm x 152cm<br>72in x 60in | Neuro Split Sheet with Pouch |
| 9048 | 20cm x 40cm<br>7in x 15in (Split)<br>228cm x 260cm<br>90in x 102in | Adhesive Split Sheet |
| 9050 | 12cm x 16 cm<br>4.5in x 6in (Aperture)<br>228cm x 300cm<br>90in x 118in | Adhesive Aperture Drape |
| 9051 | 12cm x 12cm<br>4.5in x 4.5in (Aperture)<br>183cm x 315cm<br>72in x 124in | Thyroid Drape |
| Catalog Number(s) | Dimensions | Name/Descriptor |
| 9052 | 15cm x 25cm (5.9in x 9.8in) | Hand Drape |
| | Film with 3cm | |
| | (1 in) Circle Aperture | |
| | 355cm x 293cm | |
| | 140in x 115in | |
| | | |
| 9053 | 11cm x 26cm (4.3in x 10in) | Extremity Drape |
| | Film with 6cm x 8cm (2in x | |
| | 3in) Aperture | |
| | 228cm x 300cm | |
| | 89in x 118in | |
| 9054 | 15cm x 25 cm (5.9in x 9.8in) | Hand and Foot Drape |
| | Film with 3cm | |
| | (1 in) Circle Aperture | |
| | 195cm x 300cm | |
| | 77in x 118in | |
| 9055 | 34cm x 39cm (13in x 15in) | Hip Drape with Pouches |
| | Film with 20cm x 17.5cm (8in | |
| | x 7in) Aperture | |
| | 300cm · 118in (Width Top) | |
| | 57cm · 22in | |
| | (Width Bottom) 353cm · 139in | |
| | (Length) | |
| | 246cm 96in (Length of | |
| | Pouches) | |
| | 228cm · 90in (Total Overall | |
| | Width Bottom) | |
| | | |
| 9056 | 25cm x 50cm (9.8in x 19.6 in) | Bilateral Foot Drape |
| | Film with 4cm (1.5in) Circle | |
| | Aperture | |
| | 195cm x 300cm | |
| | 77in x 118in | |
| 9057 | 11cm x 26 cm (4.3in x 10in) | Extremity Drape with Anesthesia |
| | Film with 6cm x 8cm (2in x | Screen |
| | 3in) Aperture | |
| | 292cm · 115in (Width Top) | |
| | 228cm · 89in (Width Bottom) | |
| | 305cm · 120in (Length) | |
| 9058 | 11cm x 26 cm (4.3in x 10in) | Bilateral Knee Drape |
| | Film with 6cm x 8cm (2in x | |
| | 3in) Aperture | |
| | 228cm x 300cm | |
| | 90in x 118in | |
| Catalog Number(s) | Dimensions | Name/Descriptor |
| 9062 | 30cm x 10cm<br>12in x 4in (Aperture)<br>254cm · 100in (Width Top)<br>183cm · 72in (Width Bottom)<br>285cm · 112in (Length) | Laparotomy Drape-Transverse |
| 9063 | 10cm x 30cm<br>4in x 12in (Aperture)<br>254cm · 100in (Width Top)<br>183cm · 72in (Width Bottom)<br>285cm · 112in (Length) | Laparotomy Drape |
| 9066 | 85cm x 85cm<br>33in x 33in<br>Cuff is 25 cm of the 85 cm. | Under Buttock Drape with Cuff |
| 9067 | 45cm x 37cm<br>17.75in x 14.5in | Drape Sheet |
| 9069 | 90cm x 75cm<br>36in x 30in | Drape Sheet |
| 9070 | 114cm x 87cm<br>45in x 34in | Turban Drape Sheet |
| 9071 | 97cm x 97cm<br>38 in x 38in | Drape Sheet |
| 9072 | 114cm x 150cm<br>44in x 59in | Drape Sheet |
| 9074 | 150cm x 150cm<br>59in x 59in | Instrument Table Cover/Drape Sheet |
| 9077 | 200cm x 150cm<br>78in x 59in | Drape Sheet |
| 9079 | 200cm x 228cm<br>78in x 90in | Drape Sheet |
| 9083 | 55cm x 55cm<br>19.75in x 19.75in | Adhesive Towel Drape |
| 9084 | 75cm x 75cm<br>29in x 29in | Adhesive Towel Drape |
| 9085 | 100cm x 85cm<br>39in x 33in | Adhesive Towel Drape |
| 9085W | 115cm x 97cm<br>45in x 38in | Adhesive Towel Drape |
| 9086 | 100cm x75cm<br>39in x 29in | Adhesive Towel Drape |
| 9087 | 183cm x 183cm<br>72in x 72in | Adhesive Drape Sheet |
| 9088 | 250 cm x 150 cm<br>98in x 59in | Adhesive Drape Sheet |
| 9089 | 170cm x 170cm<br>67in x 67in | Adhesive Drape Sheet |
| Catalog Number(s) | Dimensions | Name/Descriptor |
| 9090 | 300cm x 228cm<br>118in x 90in | Adhesive Drape Sheet |
| 9196 | 16cm x 95cm<br>6in x 37in (Split)<br>228cm x 260cm<br>90in x 102in | Shoulder Split Sheet with Pouch |
Table 1 – Product Catalog Numbers, Dimensions and Name/Descriptor
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The above catalog numbers are also available in non-sterile versions and are designated by NS following the catalog number.
*Note: 1190NS and 9033NS are only available in a non-sterile version.
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Table 1 – Product Catalog Numbers, Dimensions and Name/Descriptor
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The above catalog numbers are also available in non-sterile versions and are designated by NS following the catalog number.
*Note: 1190NS and 9033NS are only available in a non-sterile version.
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#### 510(k) Summary K140330
This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92.
#### Owner's Name
3M Health Care 3M Center, Building 275-5W-06 St. Paul, MN 55144
#### Contact Person
Mark Burville Regulatory Affairs Manager Telephone: 1-651-737-2027 Fax: 1-651-732-8822 E-Mail: mcburville@mmm.com
# Date Summary Prepared
July 14, 2014
#### Trade/Proprietary Name
3M™ Steri-Drape™ Fabric Surgical Drapes
#### Common/Usual Name
Drapes, Surgical
#### Classification Name
Surgical drape and drape accessories
#### Product Code: KKX per 21CFR 878.4370
Benito Perez
Predicate Devices 3M Steri-Drape Surgical Fabric Drapes K031287
#### Intended Use
3M Steri-Drape Fabric Surgical Drapes are used to create a sterile field for surgical procedures. They are provided sterile and intended for external use only.
3M Steri-Drape non-sterile fabric drapes are provided to other manufacturers for further processing using ethylene oxide. 3M provides information on compatibility with ethylene oxide (EtO) processing.
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Non-sterile surgical drapes are sold to repackager or relabeler establishments for EtO sterilization according to ISO 11135-1:2007. Sterile surgical drapes are sold directly to end users after EtO sterilization validation to ISO 11135-1:2007.
# Description of Device
The 3M Steri-Drape Fabric Surgical Drapes are one-piece, dual layer, single use disposable drapes with an AAMI Level 4 Liquid Barrier. The drapes are made of a blue absorbent nonwoven fabric thermally bonded to a blue protective barrier film. The drapes are intended to be placed over the patient prior to surgery and are designed to provide an absorbent sterile barrier during surgical procedures and stop fluid strike-through to protect the surgical site and patient from microbial penetration.
Steri-Drape Fabric Surgical Drapes are either provided sterile to end-users or non-sterile to kit manufacturers for further processing including EtO sterilization according to ISO 11135-1:2007
The drapes are provided in multiple sizes and shapes to meet the requirements of various clinical procedures. In general, the surgeon delineates the proposed field of surgery and charges the nursing team with the responsibility of draping the patient using different types of drapes. All models utilize the same material technology.
The following tables list the catalog numbers of the drapes that are included within the scope of this submission. The drapes are separated into categories based on similarity of the design and features. The categories are as follows:
Category 1 - These drapes are comprised entirely of a non-woven/film construction and may or may not feature an aperture. The entire non-woven/film portion of the drape is considered an AAMI Level 4 Barrier, with the barrier continuing to the edge of the aperture. Any component material attached to or configured within the aperture is identical to that used in the corresponding, currently marketed, predicate drapes.
Category 2 –These drapes are comprised of a non-woven / film construction and also contain either a film area with aperture or incise area. The AAMI Level 4 Barrier non-woven/film portion of the drape continues to the edge of the film or incise area. The component materials of the film area with aperture or incise area are identical to those used in the corresponding, currently marketed, predicate drapes.
Category 3 - These drapes are comprised entirely of a non-woven/film construction and feature an aperture. Additionally, these drapes include an extra absorbent layer on top of the drape and side film segments. The entire non-woven woven portion of the drape is considered an AAMI Level 4 Barrier with the barrier continuing to the edge of the aperture. The extra absorbent layer on top of the drape are illustrated with a crosshatch. and side film segments are identical to those used in the corresponding, currently marketed, predicate drapes and do not impact barrier performance of the non-woven/film portion.
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#### Category 1
| Catalog<br>Number(s) | Approximate Dimensions | Name/Descriptor | AAMI Level 4<br>Barrier |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|---------------------------------|
| 1031 | 27cm x 30cm<br>…
