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General product information only, not medical advice. This page describes what supply packs and instrument sets are and how they are labeled; it does not describe how any procedure is performed.
Purpose and setting
A C-section kit is a pre-assembled set of supplies for a cesarean delivery in an operating room. The term covers two different products that are often confused: a pack of single-use drapes and covers, and an instrument set of reusable steel instruments. This guide is for supply and sterile-processing staff and anyone reading a product listing who needs to know which one a kit actually is, what the examples on the market contain, and how FDA identifies them. It is not about consumer post-operative “recovery kits”, which are a separate product category and are not covered here.
For the vaginal-birth side, see the birthing center supply checklist. For the underlying drape product, see what a sterile drape is.
Checklist table: what is in a C-section kit
Cesarean section kit: drapes and covers (example packs)
Lohmann & Rauscher lists three sterile C-section drape sets on its Raucodrape product page (checked 2026-10-31). They show what a drape pack typically holds.
| Item | PRO Set I (REF 33361) | SMART Set (REF 33861) | PRO Set II (REF 33362) |
|---|---|---|---|
| Table cover | 1 × 150×190 cm | 1 × 150×190 cm | 1 × 150×190 cm |
| Towels | 4 × 30×40 cm | 4 × 30×20 cm | 4 × 30×40 cm |
| Instrument table cover | 1 × 80×145 cm | 1 × 80×145 cm | 1 × 80×145 cm |
| Baby drape | 1 × 90×100 cm | 1 × 90×90 cm | 1 × 90×100 cm |
| C-section drape | 1 × 260/200×335 cm | 1 × 230/200×312 cm | 1 × 260×310 cm, integrated leggings |
| Abdominal fenestration | 27×33 cm | 27×33 cm | 27×33 cm |
| Adhesive film | Elastic film with fenestration, 14×20 cm | Integrated incise film; adhesive strips 1 × 9×50 cm | Film 14×20 cm |
| Fluid collection pouch with drainage port | Integrated | Integrated | Integrated |
| Armrest cover | Yes | Yes | Yes |
| Tube fixations | Integrated | Not listed | Not listed |
All three are listed as sterile. The manufacturer also sells the baby drape alone (REF 33160) as a fluid-absorbent nonwoven, 90×100 cm.
Instruments (example set)
Instruments come as a separate product. MSF’s supply catalogue lists a “Caesarean section set, 23 instruments” (checked 2026-10-31). Per set:
| Instrument | Quantity |
|---|---|
| Sterilization basket, wired, 24×25×10 cm | 1 |
| Backhaus towel clamps, 13 cm | 4 |
| Bengolea haemostatic forceps, 20 cm, curved | 2 |
| Kelly forceps, 14 cm, curved | 2 |
| Kocher forceps, 14 cm, 1×2 teeth | 2 |
| Dressing forceps, 14.5 cm | 1 |
| Duval tissue-grasping forceps, 23 cm | 4 |
| Tissue forceps, 1×2 teeth, 14.5 cm | 1 |
| Gallipot, 100 ml | 1 |
| Mayo-Hegar needle holder, 18 cm | 1 |
| Gosset abdominal retractor, 58 mm | 1 |
| Farabeuf retractor, pair, 15 cm | 1 |
| Scalpel handle no. 4 | 1 |
| Metzenbaum scissors, curved, 18 cm | 1 |
| Mayo scissors, curved, 17 cm | 1 |
Not included
- Scalpel blades. The MSF set does not include them; the catalogue lists them as a separate article (code ESURSCALB22).
What varies between kits
Pack versus instrument set
A drape pack (single-use textile or nonwoven items) and an instrument set (reusable steel in a sterilization basket) are different products from different suppliers. A listing that says “C-section kit” may mean either, so check the contents list.
Sterile versus not sterile
Labeling differs between kits. The Lohmann & Rauscher sets above are sterile. In contrast, the NLM AccessGUDID record for Cardinal Health’s “KIT, C SECTION, HEALTH SYST” (device identifier 10888439621747, checked 2026-10-31) states the kit is not labeled as packaged sterile and does not require sterilization prior to use. Read the label of the exact catalog number.
C-section kit versus labor and delivery kit
They are different FDA product codes (see below). A labor and delivery kit is not a cesarean kit.
Storage, expiry and restocking
The Cardinal record in AccessGUDID is a single-use device, not made with natural rubber latex, one unit per case, with an expiration date on the label (no shelf-life duration is recorded) and storage “between 15 and 30 degrees Celsius”. Another manufacturer’s kit may differ, so follow the label and instructions for use that ship with the product you stock.
Standards and rules that apply
FDA product codes
In the openFDA device classification database (checked 2026-10-31):
- OHM: “Cesarean Section Tray”, class 2, obstetrics and gynecology panel. The record lists regulation number 884.1720, as listed in the FDA record.
- MLS: “Labor And Delivery Kit”, class 2, regulation number 884.4530.
Both records describe the product as established under the May 20, 1997 “Convenience Kits Interim Regulatory Guidance”, under enforcement discretion, and not requiring a premarket notification (510(k)) if it meets all criteria in that guidance.
Convenience kit guidance
FDA’s guidance (checked 2026-10-31) covers legally marketed devices “simply being assembled in kit form strictly for the ‘convenience’ of the purchaser or user”. Enforcement discretion applies only if all of these hold: the kit type is on FDA’s list; the components are cleared by 510(k), preamendments or exempt, and bought in finished form; and the assembler can reasonably conclude that further processing, such as sterilization, does not significantly affect the safety or effectiveness of any component. Kits stay subject to general controls, including misbranding, and the assembler keeps documentation under the quality system regulation.
C section drape: 21 CFR 878.4370
A surgical drape is defined in 21 CFR 878.4370 (Cornell LII copy, checked 2026-10-31) as “a device made of natural or synthetic materials intended to be used as a protective patient covering”. It is class II (special controls). The rule exempts listed types from 510(k), including “a surgical drape that does not include an antimicrobial agent”, subject to the limitations in 21 CFR 878.9. openFDA lists drapes under PUI (“Drape, Surgical, Exempt”) and KKX (“Drape, Surgical, Antimicrobial”), both under 878.4370, class 2. For the general device concept, see what is a medical device.
FAQ
What is in a C-section kit?
It depends on which product is meant. A drape pack typically holds a table cover, towels, an instrument table cover, a baby drape, a large C-section drape with an abdominal fenestration, adhesive film, a fluid pouch and an armrest cover. An instrument set holds reusable steel instruments such as clamps, forceps, retractors, a needle holder, scissors and a scalpel handle, with blades sold separately in the MSF example.
What is a cesarean (c-section) drape?
It is the large sterile sheet of a drape pack that covers the patient and has an abdominal fenestration (27×33 cm in the three examples above). Under 21 CFR 878.4370 it is a class II surgical drape.
Is a C-section kit the same as a labor and delivery kit?
No. FDA lists them under different product codes: OHM for the cesarean section tray and MLS for the labor and delivery kit.
Is a recovery kit the same thing?
No. Consumer post-operative recovery kits are a different category from the operating-room packs and instrument sets described here, and nothing on this page applies to them.
Sources
- openFDA, device classification, product codes MLS and OHM (checked 2026-10-31).
- FDA, Convenience Kits Interim Regulatory Guidance (checked 2026-10-31).
- 21 CFR 878.4370, Surgical drape and drape accessories (checked 2026-10-31).
- Lohmann & Rauscher, Raucodrape C-section drapes (checked 2026-10-31).
- MSF Supply Catalogue, Caesarean section set, 23 instruments (checked 2026-10-31).
- NLM AccessGUDID, device identifier 10888439621747 (checked 2026-10-31).
Related: wound closure kit, what is a surgical gown.
